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.