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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.
- 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.
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Date created: May 1, 2006
Date updated: October 11, 2006 |
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