Drugs

Drug Development and Drug Interactions: Advisory Committee Meetings

2006

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]

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.
- Presentation slides
- Transcripts
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.