Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

Posted on March 01, 2012

Cardiovascular and Renal Drugs Advisory Committee

• Slides for the February 23, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee¹
• Chelsea Presentations for the February 23, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 5.42MB)² (PDF - 5.2MB)
• FDA Presentations for the February 23, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 697KB)³ (PDF - 620KB)
• Final Meeting Roster for the February 23, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee⁴ (PDF - 29KB)
• Final Questions for the February 23, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee⁵ (PDF - 41KB)
• 2012 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee⁶
• Final Agenda for the February 23, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee⁷ (PDF - 42KB)

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Posted on February 29, 2012

Pulmonary-Allergy Drugs Advisory Committee

• Webcast Information for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee⁸ (PDF - 29KB)
• Slides for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee⁹
• Forest Presentations for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 421KB)¹⁰ (PDF - 421KB)
• FDA Backup Presentations for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 29KB)¹¹ (PDF - 27KB)
• FDA Main Presentations for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 1.49MB)¹² (PDF - 536KB)
• Final Meeting Roster for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee¹³ (PDF - 22KB)
• Final Questions for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee¹⁴ (PDF - 12KB)
• Final Agenda for the February 23, 2012 Meeting of the Pulmonary-Allergy Drugs Advisory Committee¹⁵ (PDF - 18KB)
• Pulmonary-Allergy Drugs Advisory Committee¹⁶

Endocrinologic and Metabolic Drugs Advisory Committee

• Slides for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee¹⁷
• Guest Presentations for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 285KB)¹⁸ (PDF - 249KB)
• Vivus Backup Presentations for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 529KB)¹⁹ (PDF - 529KB)
• Vivus Main Presentations for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 647KB)²⁰ (PDF - 627KB)
• FDA Presentations for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 862KB)²¹ (PDF - 524KB)
• Final Meeting Roster for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee²² (PDF - 34KB)
• Final Questions for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee²³ (PDF - 13KB)
• Final Agenda for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee²⁴ (PDF - 27KB)
• 2012 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee²⁵

Advisory Committee Calendar

• March 1-2, 2012 - Tobacco Products Scientific Advisory Committee Meeting Announcement²⁶

Endocrinologic and Metabolic Drugs Advisory Committee

• Webcast Information for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee²⁷ (PDF - 15KB)

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Posted on February 28, 2012

Oncologic Drugs Advisory Committee

• Minutes for the February 9, 2012 Meeting of the Oncologic Drugs Advisory Committee²⁸ (PDF - 71KB)
• 2012 Meeting Materials, Oncologic Drugs Advisory Committee²⁹
• Minutes for the February 8, 2012 Meeting of the Oncologic Drugs Advisory Committee³⁰ (PDF - 27KB)

Endocrinologic and Metabolic Drugs Advisory Committee

• Briefing Information for the July 19, 2011 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee³¹

Science Board to the Food and Drug Administration

• CDER response to Subcommittee’s Review of the Pharmacovigilance Program³² (PDF - 811KB)

Endocrinologic and Metabolic Drugs Advisory Committee

• Errata (2) to the FDA Briefing Information for the July 19, 2011 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF – 9KB)³³ (PDF - 8KB)

Advisory Committee Calendar

• April 2, 2012: Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee Meeting Announcement³⁴

Nonprescription Drugs Advisory Committee

• 2012 Meeting Materials, Nonprescription Drugs Advisory Committee³⁵

Anti-Infective Drugs Advisory Committee

• 2012 Meeting Materials, Anti-Infective Drugs Advisory Committee³⁶

Advisory Committee Calendar

• March 27, 2012: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement³⁷

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• Vinks_Disclosure Document for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-14KB)³⁸ (PDF - 19KB)
• Mager_Disclosure Document for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-14KB)³⁹ (PDF - 19KB)
• 18 U.S.C. 208(a) and 712(c)(2)(B) Waivers for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-22KB)⁴⁰ (PDF - 34KB)
• Capparelli_Disclosure Document for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-14KB)⁴¹ (PDF - 19KB)
• 18 U.S.C. 208(a) and 712(c)(2)(B) Waivers for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-157KB)⁴² (PDF - 168KB)
• Disclosure Document for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-14KB)⁴³ (PDF - 19KB)
• Waivers for Conflicts of Interest for the March 14, 2012 Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology⁴⁴
• 18 U.S.C. 208(a) and 712(c)(2)(B) Waivers for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-263KB)⁴⁵ (PDF - 266KB)
• 18 U.S.C. 208(a) and 712(c)(2)(B) Waivers for the March 14, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF-249KB)⁴⁶ (PDF - 252KB)
• 2012 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee⁴⁷