Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement Committee Meeting September 10, 2013, from 8 a.m. to 3 p.m. The committee will discuss the new molecular entity (NME) new drug application (NDA) 203975 for umeclidinium and vilanterol powder for inhalation (proposed tradename Anoro Ellipta), sponsored by Glaxo Group (d/b/a/ GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Cardiovascular and Renal Drugs AdComm

Cardiovascular and Renal Drugs AdComm Committee Meeting August 5th, 2013, 2013, from 8 a.m. to 5:30 p.m.4 On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure).

Cardiovascular and Renal Drugs Advisory Committee Meeting

Cardiovascular and Renal Drugs Advisory Committee Meeting Committee Meeting August 5th, 2013, 2013, from 8 a.m. to 5:30 p.m. On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA''''s Web site after the meeting.

Tobacco Product Analysis - A Scientific Workshop - July 2013

Tobacco Product Analysis - A Scientific Workshop - July 2013 Committee Meeting July 31, 2013 from 8:30 a.m. to 4:30 p.m. ET (Day 2 of 2) Agenda:The purpose of this workshop is to discuss and obtain input on the chemical analysis of tobacco products. Tobacco product analysis experts from academia, industry, government, and contract testing laboratories will share information on understanding the testing of cigarette smoke and tobacco filler from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for tar, nicotine, and carbon monoxide (TNCO), tobacco-specific nitrosamines (TSNAs), and polycyclic aromatic hydrocarbons (PAHs). FDA will invite speakers to address specific scientific and technical matters related to TNCO in cigarette smoke TSNAs (total TSNAs, NNN, and NNK) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) PAHs (benzo[a]pyrene, naphthalene, chrysene, benz[j]anceanthrylene, benzo[a]anthracene, benzo[b]fluoroanthene, benzo[k]fluoroanthene, benzo[c]phenanthrene, cyclopenta[cd]pyrene, dibenz[a,h]anthracene, dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene, indeno[1,2,3-cd]pyrene, and 5-methylchrysene) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) General method testing for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke Validation or method performance for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke

Tobacco Product Analysis - A Scientific Workshop - July 2013

Tobacco Product Analysis - A Scientific Workshop - July 2013 Committee Meeting July 30, 2013 from 8:30 a.m. to 5:30 p.m. ET (Day 1 of 2) Agenda:The purpose of this workshop is to discuss and obtain input on the chemical analysis of tobacco products. Tobacco product analysis experts from academia, industry, government, and contract testing laboratories will share information on understanding the testing of cigarette smoke and tobacco filler from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for tar, nicotine, and carbon monoxide (TNCO), tobacco-specific nitrosamines (TSNAs), and polycyclic aromatic hydrocarbons (PAHs). FDA will invite speakers to address specific scientific and technical matters related to TNCO in cigarette smoke TSNAs (total TSNAs, NNN, and NNK) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) PAHs (benzo[a]pyrene, naphthalene, chrysene, benz[j]anceanthrylene, benzo[a]anthracene, benzo[b]fluoroanthene, benzo[k]fluoroanthene, benzo[c]phenanthrene, cyclopenta[cd]pyrene, dibenz[a,h]anthracene, dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene, indeno[1,2,3-cd]pyrene, and 5-methylchrysene) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) General method testing for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke Validation or method performance for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting July 25th, 2013 8:00 a.m. - 6:00 p.m. (Day 2 of 2) On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5-S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting July 24th, 2013 8:00 a.m. - 6:00 p.m. (Day 1 of 2) On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space.

Arthritis Advisory Committee Meeting Announcement

Arthritis Advisory Committee Meeting Announcement July 23, 2013, from 8 a.m. to 5:30 p.m. (Day 2 of 2) Agenda: During the morning session, the committee will discuss supplemental biologic license application (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc. for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein (CRP) or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug. During the afternoon session, the committee will discuss (sBLA) 125160, CIMZIA (certolizumab) injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis.

Arthritis Advisory Committee Meeting Announcement

Arthritis Advisory Committee Meeting Announcement Committee Meeting July 22, 2013, from 8 a.m. to 4 p.m. (Day 1 of 2) Agenda: The committee will discuss the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval.

Dental Products Panel of the Medical Devices Advisory Committee Meeting

Dental Products Panel of the Medical Devices Advisory Committee Meeting Committee Meeting July 18, 2013 8:30 a.m. - 2:30 p.m. Agenda: On July 18, 2013, the committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. The Class III blade-form endosseous dental implant is a device placed into the maxilla or mandible and composed of biocompatible material, such as commercially pure titanium, with sufficient strength to support a dental restoration, such as a crown, bridge, or denture, intended for the purpose of replacing tooth (or teeth) roots and extending a support post through the gingival tissue into the oral cavity to restore chewing function. The blade-form implant is generally a rectangular shape or rounded corner rectangle shape (in the mesio-distal plane) with a narrow tapered (narrow at the apical edge) edge (in the bucco-lingual plane) similar in shape to a razor blade. Other blade designs, such as square, V-shaped, and triangles have also been used. The blade-form implants are either one-piece or two-piece implants designed with one to three cylindrical abutment posts extending from the coronal aspect of the blade through the soft tissue and into the oral cavity. On January 4, 2013 (FDA-2012-N-0677), FDA issued a proposed order which, if made final, would reclassify the blade-form endosseous dental implant into class II (special controls). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm Class III or reclassify these devices into Class II and comment on whether the proposed Special Controls are adequate to reasonably ensure the safety and effectiveness of blade-form endosseous dental implants. The regulatory history of blade-form endosseous dental implant has been discussed as part of the proposed order (FDA-2012-N-0677).

Anesthetic and Analgesic Drug Products Advisory Committee

Anesthetic and Analgesic Drug Products Advisory Committee Committee Meeting July 18, 2013, from 8 a.m. to 5 p.m. (Day 2 of 2) Agenda: On July 18, 2013, the committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at 3 minutes after administration of rocuronium.

Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement Committee Meeting July 17, 2013, from 8 a.m. to 5 p.m. The committee will discuss the safety and efficacy for the new drug application (NDA) 203077, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, submitted by QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement

Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement Committee Meeting July 10, 2013, from 8 a.m. to 5 p.m. Agenda: The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of Lotronex (alosetron hydrochloride) tablets, Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Committee Meeting June 27, 2013 8:00 a.m. - 6:00 p.m. Agenda: On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient''''''''s blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”'''''''' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement

General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement Committee Meeting June 26, 2013, from 8 a.m. to 5 p.m. Agenda: On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Committee Meeting June 6, 2013 from 8 a.m. to 5 p.m. (Day 2 of 2) Agenda: On June 5 and 6, 2013, the committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Committee Meeting June 5, 2013 from 8 a.m. to 5 p.m. (Day 1 of 2) Agenda: On June 5 and 6, 2013, the committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee Committee Meeting May 22, 2013, from 8 a.m. to 5 p.m. Agenda: On May 22, 2013, the committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting Committee Meeting May 3, 2013 8:00 a.m. to 5:00 p.m. Agenda: The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE (sargramostim, Genzyme, Inc.), and 125294, TBO-FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs.

General and Plastic Surgery Devices Panel of the Medical Devices Meeting

General and Plastic Surgery Devices Panel of the Medical Devices Meeting Committee Meeting May 2, 2013 8:00 a.m. - 6:00 p.m. Agenda: On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juvederm Voluma XC sponsored by Allergan, Inc. Juvederm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juvederm Voluma XC isindicated for deep (dermal/subcutaneous and/or ubmuscular/supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

Meeting of the Oncologic Drugs Advisory Committee Meeting

Meeting of the Oncologic Drugs Advisory Committee Meeting Committee Meeting May 2, 2013 8:00 a.m. to 5:00 p.m. Agenda : During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma. During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee Committee Meeting April 30, 2013, from 8:30 a.m. to 5:30 p.m. Agenda: Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Before an MRTP can be introduced or delivered for introduction into interstate commerce, an order from FDA under section 911(g) (21 U.S.C. 387k(g)) of the Federal Food, Drug, and Cosmetic Act (FD Act) must be in effect with respect to the tobacco product. 21 U.S.C. 387k(a). Any person may submit an application seeking an order under section 911(g) of the FD Act.Show citation box Section 911(f) of the FD Act (21 U.S.C. 387k(f)) requires FDA to refer modified risk tobacco product applications to the Tobacco Products Scientific Advisory Committee (TPSAC) for its recommendations. TPSAC is required to report its recommendations on an application to FDA no later than 60 days after the date the application is referred to them. 21 U.S.C. 387k(f)(2). On April 30, 2013, FDA will present information to the committee on the process it will use to refer individual modified risk tobacco product applications to TPSAC.

Risk Communication Advisory Committee Meeting

Risk Communication Advisory Committee Meeting Committee Meeting April 30, 2013 8:00 a.m. - 12:00 p.m. (Day 2 of 2) Agenda : The Committee will discuss how to communicate effectively about FDA’s adverse event reporting system.

Risk Communication Advisory Committee Meeting

Risk Communication Advisory Committee Meeting Committee Meeting April 29, 2013 8:00 a.m. - 4:00 p.m. (Day 1 of 2) Agenda: The Committee will discuss general factors in risk communication about FDA regulated products, including messaging in the context of competing communicators.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 26, 2013 8:00 a.m. - 6:00 p.m. (Day 2 of 2) Agenda: On April 26, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 25, 2013 8:00 a.m. - 6:00 p.m. (Day 1 of 2) Agenda: On April 25, 2013, during session I, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Methotrexate,” Product Code LAO, as unclassified under the 510(k) premarket notification authority. Methotrexate enzyme immunoassays are for the quantitative determination of methotrexate. The measurements obtained are used in monitoring levels of methotrexate to ensure appropriate drug therapy. FDA is seeking panel input on the safety and effectiveness of methotrexate enzyme immunoassays. On April 25, 2013, during session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Phencyclidine,” Product Code LCM, and “Radioimmunoassay, Phencyclidine,” Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays.

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee Committee Meeting April 18, 20138:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil microembolism in the lungs and potential anaphylactic reactions. In addition to AVEED, other approved testosterone injectable products will be referenced, especially in regard to oil embolism and potential anaphylactic reactions reported for those products.

Pulmonary-Allergy Drugs Advisory Committee

Pulmonary-Allergy Drugs Advisory Committee Committee Meeting April 17, 2013 8:00 a.m. to 5:00 p.m. Agenda : The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee Committee Meeting April 18, 20138:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil microembolism in the lungs and potential anaphylactic reactions. In addition to AVEED, other approved testosterone injectable products will be referenced, especially in regard to oil embolism and potential anaphylactic reactions reported for those products.

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting Committee Meeting May 3, 2013 8:00 a.m. to 5:00 p.m. Agenda: The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE (sargramostim, Genzyme, Inc.), and 125294, TBO-FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs.

Meeting of the Oncologic Drugs Advisory Committee Meeting

Meeting of the Oncologic Drugs Advisory Committee Meeting Committee Meeting May 2, 2013 8:00 a.m. to 5:00 p.m. Agenda : During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma. During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 26, 2013 8:00 a.m. - 6:00 p.m. (Day 2 of 2) Agenda: On April 26, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 25, 2013 8:00 a.m. - 6:00 p.m. (Day 1 of 2) Agenda: On April 25, 2013, during session I, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Methotrexate,” Product Code LAO, as unclassified under the 510(k) premarket notification authority. Methotrexate enzyme immunoassays are for the quantitative determination of methotrexate. The measurements obtained are used in monitoring levels of methotrexate to ensure appropriate drug therapy. FDA is seeking panel input on the safety and effectiveness of methotrexate enzyme immunoassays. On April 25, 2013, during session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Phencyclidine,” Product Code LCM, and “Radioimmunoassay, Phencyclidine,” Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays.

Device Good Manufacturing Practice Advisory Committee Meeting

Device Good Manufacturing Practice Advisory Committee Meeting Committee Meeting : April 11, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 11, 2013, the committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. The committee will further discuss how to optimize the use of FDA’s current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. In a separate Federal Register notice, FDA is seeking additional broad public input about the effects of extreme weather on medical device safety and quality.

Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting

Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting April 8, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 8, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsored by Bausch and Lomb. The Trulign Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision and reduction of residual refractive cylinder. Trulign Toric provides approximately one diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles.

Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting

Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Committee Meeting March 21, 2013 8:00 a.m. to 5:00 p.m. Agenda : On March 21, 2013, the committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee Committee Meeting March 20, 2013 8:00 a.m. - 6:00 p.m. Agenda: On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device. The MitraClip device is a single sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation. The MitraClip device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The implantable MitraClip device is fabricated with metal alloys and polyester fabric (Clip cover) that are commonly used in cardiovascular implants. The proposed indication for use: The MitraClip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR≥3) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not preclude the expected benefit from correction of the mitral regurgitation.

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop March 20th , 2013 8:30 a.m. to 5 p.m. (Day 2 of 2) Workshop Objective: The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance). FDA is also considering third party governance as it relates more generally to tobacco research. Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research.

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop March 19th, 2013 8:30 a.m. to 5 p.m. (Day 1 of 2) Workshop Objective: The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance). FDA is also considering third party governance as it relates more generally to tobacco research. Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research.

Neonatal Subcommittee of the Pediatric Advisory Committee

Neonatal Subcommittee of the Pediatric Advisory Committee Committee Meeting Friday, March 15, 2013, from 8 a.m. to 4 p.m. Agenda: The Food and Drug Administration Safety and Innovation Act identified the need to expand current pediatric science to include the neonatal population. On March 15, 2013,FDA’s Neonatal Subcommittee of the Pediatric Advisory Committee will convene a non-voting session to establish an operational framework for the subcommittee as well as discuss and comment on nonspecific matters pertaining to neonatology. The subcommittee will also comment on ways to approach the challenges and identify different programmatic strategies foradvancing the knowledge necessary to developing neonatal regulatory science.

Pediatric Advisory Committee Meeting

Pediatric Advisory Committee Meeting Committee Meeting March 14, 20138:00 a.m. - 5:30 p.m. Agenda: On Thursday, March 14, 2013, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Acterma (tocilizumab), Alimta (pemetrexed disodium), Creon (pancrelipase), Gadavist (gadobutrol), Hizentra [Immune Globulin Subcutaneous (Human), 20% Liquid], Inomax (nitric oxide), Invega (paliperidone), Kedbumin (albumin human), Kytril Injection (granisetron hydrochloride), Lamictal XR (lamotrigine), Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine], Moxeza (moxifloxacin ophthalmic solution 0.5%), Natroba (spinosad), Nexium (esomeprazole magnesium), Nexium IV (esomeprazole sodium), Uroxatral (alfuzosin hydrochloride), and Zenpep (pancrelipase). Also, there will be an Informational Update on Codeine.

Vaccines and Related Biological Products Advisory Committee Meeting

Vaccines and Related Biological Products Advisory Committee Meeting Committee meeting February 27, 2013 between approximately 8:30 a.m. and 2:45 p.m. Agenda: On February 27, 2013, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013-2014 influenza season.

Impact of Approved Drug Labeling on Chronic Opioid Therapy

Impact of Approved Drug Labeling on Chronic Opioid Therapy The public hearing will be held on February 7 and 8, 2013, from 9 a.m. to 4 p.m. (Day 2 of 2) The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.

Impact of Approved Drug Labeling on Chronic Opioid Therapy

Impact of Approved Drug Labeling on Chronic Opioid Therapy The public hearing will be held on February 7 and 8, 2013, from 9 a.m. to 4 p.m. (Day 1 of 2) The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Meeting

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Meeting Committee Meeting March 5, 2013 8:00 a.m. to 4:00 p.m. Agenda: The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include Miacalcin (calcitonin salmon) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin salmon recombinant) nasal spray, Upsher Smith Laboratories; and the generic equivalents of these products.

Reproductive Health Drugs Advisory Committee Meeting

Reproductive Health Drugs Advisory Committee Meeting Committee Meeting March 4, 2013 8:00 a.m. to 5:00 p.m. Agenda : On March 4, 2013, during the morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause. During the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopa

Medical Imaging Drugs Advisory Committee

Medical Imaging Drugs Advisory Committee Committee Meeting February 14, 2013 8:00 a.m. to 3:00 p.m. Agenda: The committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation).