Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting October 29, 2012 from 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: On October 29 and 30, 2012, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products.

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting October 29, 2012 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: On October 29 and 30, 2012, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products.

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Ophthalmic Devices Panel of the Medical Devices Advisory Committee Committee Meeting September 28, 2012 8:00 a.m. - 6:00 p.m. Agenda: On September 28, 2012, the committee will discuss, make recommendations and vote on information regarding the humanitarian device exemption (HDE) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. The proposed Indication for Use for the Argus II (as stated in the HDE) is as follows: The Argus II System is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria: • Adults, age 25 years or older. • Bare light or no light perception in both eyes with Snellen acuity worse than 20/2100 or 2.1 logMAR. If the patient has no residual light perception, the retina must be able to respond to electrical stimulation as evidenced by an electrically evoked response. • Previous history of useful form vision.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting September 21, 2012 8:00 a.m. - 6:00 p.m. Agenda: On September 21, 2012, the committee will discuss and make recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.

Vaccines and Related Biological Products Advisory Committee Meeting

Vaccines and Related Biological Products Advisory Committee Meeting Committee Meeting September 19, 2012 between approximately 8:00 a.m. and 4:00 p.m. Agenda: On September 19, 2012, the committee will meet in open session to discuss consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture.

Cardiovascular and Renal Drugs Advisory Committee Meeting

Cardiovascular and Renal Drugs Advisory Committee Meeting Committee Meeting September 14, 2012 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss new drug application (NDA) 203446, imatinib mesylate, submitted by Novartis Pharmaceuticals Corp., as adjunctive therapy for the treatment of pulmonary arterial hypertension (WHO Diagnostic Group 1), to improve exercise capacity and cardio-pulmonary hemodynamics in patients who remain symptomatic despite treatment with two or more approved vasodilator therapies (“vasodilator therapies” refer to medicines used to dilate blood vessels and thereby reduce resistance to blood flow).

Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Committee Meeting September 5, 2012 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss new drug application (NDA) 201688, tobramycin inhalation powder, application submitted by Novartis Pharmaceuticals Corporation, and the requested indication of management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology [Committee Meeting August 9, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: During the morning session, the committee will discuss FDA''s draft guidance on tablet scoring. This topic will include an overview of FDA''s proposed plan to move forward and the United States Pharmacopoeia’s (USP) perspective on the topic. During the afternoon session, the committee will discuss: (1) the Center for Drug Evaluation and Research (CDER) Nanotechnology Risk Management Working Group activities; (2) nanotechnology-related research conducted and published by CDER, to include examples related to sunscreens; and (3) the overview and preliminary analysis of nanotechnology-related information collected from drug application submissions.

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, [Committee Meeting August 8, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)] Add To Cart 140.00 Agenda: During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting [Committee Meeting August 8, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)] Agenda: During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.