Drug Development and Drug Interactions: Advisory Committee Meetings
2013
- September 25, 2013 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
- Notice of Meeting
- Briefing Information
- Agenda
- Optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information
- Questions
- Slides
- Transcripts
- Minutes
2012 no ACPS-CP meeting
2011
- March 2, 2011 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
- Notice of Meeting
- Briefing Information
- Agenda
- Rare Disease Drug Development and Regulation
- Topic 1: Mechanistic Understanding of Disease and Response Biomarkers
- Topic 2: Clinical Pharmacology Decision Tree for Rare Diseases/Orphan Drugs
- Topic 3: Clinical Pharmacology Tools for Developing Drugs for Rare Diseases
- Topic 4: FDA Next Steps
- Rare Disease Drug Development and Regulation
- Questions
- Slides
- Transcripts
2010
- March 17, 2010 Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
- Notice of Meeting
- Briefing Information
- Agenda
- Topic 1: Clinical Pharmacogenomics in Early Drug Development
- Topic 2: Mechanistic (“Systems”) Approach to Drug Safety
- Topic 3: New Study Design and Dosing Adjustment Issues in Renal Impairment
- Topic 4: Transporter-Mediated Drug Interactions
- Questions
- Slides
- Transcripts
2009 no ACPS-CP meeting
2008
- March 18-19, 2008 Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
- Notice of meeting
- Briefing Information
- Agenda
- Topic 1: New Clinical PGx Concept Paper
- Topic 2: Quantitative Clinical Pharmacology: Critical Path Opportunities
- Topic 3: Renal Impairment Concept Paper
2007 no ACPS-CP meeting
2006
- October 18-19, 2006 Clinical Pharmacology Subcomittee Meeting
http://www.fda.gov/ohrms/dockets/ac/cder06.html#PharmScience- Notice of meeting [PDF]
- Agenda [PDF]
- Questions [PDF]
- Briefing Information
2005
- Evidence and Process for Translation of Pharmacogenetic Information (e.g., CYP 2C9 polymorphisms) into Label Updates for Approved Products, Advisory Committee for Pharmaceutical Science- Clinical Pharmacology Subcommittee meeting November 14, 2005
- Advisory Committee Information
Labeling Recommendations for Drugs/Biologics and Device Related to Pharmacogenomic Data and Test [PDF] - How New Insights into Pharmacogenomics Lead to Revisions of Product Labels [PPT]
- FDA Pharmacogenetic Labels: A clinical perspective [PPT]
- Advisory Committee Information
2004
-
Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling, discussed at the FDA Advisory Committee for pharmaceutical sciences and Clinical Pharmacology Subcommittee meeting. Issues drug interaction concept paper. Rockville, MD. November 3, 2004.
2003
-
CYP2B6/CYP2C8 Drug Interactions, Advisory Committee for Pharmaceutical Science- Clinical Pharmacology Subcommittee meeting, November 18, 2003, Rockville, MD.
-
Huang, S, Issues and Challenges in the Evaluation and Labeling of Drug Interaction Potentials of NME, Advisory Committee for Pharmaceutical Science- Clinical Pharmacology Subcommittee meeting, April 23, 2003, Rockville, MD.