Center for Drug Evaluation and Research Application Number 20-972 Clinical Pharmacology and Biopharmaceutics Review

Center for Drug Evaluation and Research Application Number 20-972 Pharmacology Review

Center for Drug Evaluation and Research Application Number 20-972 Statistical Review

Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies.

Gualberto Ruaño1,2, Jerry M Collins3, Andrew J Dorner4, Sue-Jane Wang5, Roberto Guerciolini6 & Shiew-Mei Huang†7 †Author for correspondence 1President, Genomas LLC, New Haven, CT, USA 2Department of Biochemistry and Molecular Biology, George Washington University, Washington DC, USA 3Director, Laboratory of Clinical Pharmacology, CDER, FDA, USA 4Senior Director, Molecular Medicine, Wyeth Resear...

MEMORANDUM DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration

Please find here attached the draft Clinical Pharmacology/Biopharmaceutics Review of NDA 22,527.

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 21-306 PHARMACOLOGY REVIEW(S) 1 REVIEW AND EVALUATION OF PHARMACOLOGY AND TOXICOLOGY DATA Division of Anesthetic, Critical Care, and Addiction Drug Products (HFD-170) Supplemental Review