'Pediatric exclusivity' diaporamas de présentation

Pediatric Research Equity Act June 9, 2004

Pediatric Research Equity Act June 9, 2004. Shirley Murphy, M.D. Division Director Division of Pediatric Drug Development. P ediatric R esearch E quity A ct. PREA. Became law December 3, 2003 Legislation mimics Pediatric Rule

560 views • 19 slides

Center for Professional Advancement Generic Drug Approvals Course

310 views • 19 slides

One Year Post-Exclusivity Adverse Event Review: Tolterodine Pediatric Advisory Committee Meeting June 29, 2005

One Year Post-Exclusivity Adverse Event Review: Tolterodine Pediatric Advisory Committee Meeting June 29, 2005. Lawrence Grylack, MD Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration. Background Drug Information.

439 views • 16 slides

One Year Post Exclusivity Adverse Event Review: Desloratadine Pediatric Advisory Committee Meeting September 15, 2004

One Year Post Exclusivity Adverse Event Review: Desloratadine Pediatric Advisory Committee Meeting September 15, 2004. Jane Filie, MD Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration. Background Drug Information .

866 views • 16 slides

Statistical Update

Statistical Update. March 3, 2003. Terrie L. Crescenzi, RPh Associate Director for Regulatory Affairs Office of Counter-Terrorism & Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration. Pediatric Exclusivity. Proposals from Industry 324

221 views • 9 slides

One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007

One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007. Amy M. Taylor, MD, MHS, FAAP Medical Officer Pediatric and Maternal Health Staff Office of New Drugs Food and Drug Administration. Background Drug Information.

68 views • 6 slides