Posted on August 30, 2012

Anti-Infective Drugs Advisory Committee

• Committee Roster for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 97KB)
• Draft Meeting Roster for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 104KB)
• Draft Questions for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 77KB)
• Draft Agenda for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 94KB)

Posted on August 29, 2012

Endocrinologic and Metabolic Drugs Advisory Committee

• Transcript for the March 29, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee  (PDF - 1.8MB)
• 2012 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• Topic 2: Biosimilars – An Update (PDF - 5.49MB)  (PDF - 5.6MB)
• Topic 1: Tablet Scoring (PDF - 906KB)  (PDF - 880KB)
• Topic 2: Nanotechnology – Update on FDA Activities (PDF - 2.05MB)  (PDF - 2MB)
• Topic 1: Uses and Limitations of In Vitro Dissolution Testing (PDF - 3.35MB)  (PDF - 3.8MB)

Posted on August 28, 2012

Advisory Committee Calendar

• CANCELLED September 14, 2012: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Posted on August 27, 2012

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• 2012 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Advisory Committee Calendar

• October 16, 2012: Gastrointestinal Drugs Advisory Committee Meeting Announcement

Posted on August 26, 2012

Gastrointestinal Drugs Advisory Committee

• Draft Questions for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 46KB)

Posted on August 24, 2012

Gastrointestinal Drugs Advisory Committee

• Briefing Information for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee
• Abbott Briefing Information for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF – 1.14MB)  (PDF - 1.1MB)
• Errata to the FDA Briefing Information for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF – 133KB)  (PDF - 161KB)
• FDA Briefing Information for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF – 1.15MB)  (PDF - 1.2MB)
• Committee Roster for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 18KB)
• Draft Meeting Roster for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 59KB)
• Draft Agenda for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 44KB)

Posted on August 23, 2012

Advisory Committee Calendar

• October 24, 2012: Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Posted on August 21, 2012

Oncologic Drugs Advisory Committee

• Minutes for the July 25, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 18KB)

Posted on August 20, 2012

Peripheral and Central Nervous System Drugs Advisory Committee

• Minutes for the May 24, 2012 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 42KB)
• Transcript for the May 24, 2012 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 2.1MB)
• 2012 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee

Oncologic Drugs Advisory Committee

• Minutes for the July 24, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 27KB)

Posted on August 17, 2012

Advisory Committee Calendar

• October 18, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Posted on August 16, 2012

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• Slides for the August 9, 2012 Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
• Slides for the August 8, 2012 Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Posted on August 15, 2012

Dermatologic and Ophthalmic Drugs Advisory Committee

• Final Questions for the July 26, 2012 Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (PM Session)  (PDF - 13KB)

Advisory Committee Calendar

• October 17, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Posted on August 03, 2012

Orthopaedic and Rehabilitation Devices Panel

• Outcomes: Industry Presentation Smith & Nephew - Day 2  (PDF - 123KB)

Posted on August 02, 2012

Drug Safety and Risk Management Advisory Committee

• Drug Safety and Risk Management Advisory Committee Roster

Posted on August 01, 2012

Advisory Committee Calendar

• September 20-21, 2012: Meeting of the Blood Products Advisory Committee Announcement

Posted on July 31, 2012

Reproductive Health Drugs Advisory Committee

• Reproductive Health Drugs Advisory Committee

Pulmonary-Allergy Drugs Advisory Committee

• Pulmonary-Allergy Drugs Advisory Committee

Psychopharmacologic Drugs Advisory Committee

• Psychopharmacologic Drugs Advisory Committee

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee

• Peripheral and Central Nervous System Drugs Advisory Committee

Nonprescription Drugs Advisory Committee

• Nonprescription Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee

• Gastrointestinal Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee

• Endocrinologic and Metabolic Drugs Advisory Committee

Dermatologic and Ophthalmic Drugs Advisory Committee

• Dermatologic and Ophthalmic Drugs Advisory Committee

Antiviral Drugs Advisory Committee

• Antiviral Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee

• Anti-Infective Drugs Advisory Committee

Anesthetic and Analgesic Drug Products Advisory Committee

• Anesthetic and Analgesic Drug Products Advisory Committee

Posted on July 30, 2012

Advisory Committee Calendar

• September 11, 2012: Pediatric Advisory Committee Meeting Announcement

Antiviral Drugs Advisory Committee

• 2012 Meeting Materials, Antiviral Drugs Advisory Committee

Orthopaedic and Rehabilitation Devices Panel

• Transcript: June 28, 2012  (PDF - 1.5MB)