'Drug administration modernization act' diaporamas de présentation

The Future of Combination Products

The Future of Combination Products. Bradley Merrill Thompson, MBA, JD, RAC Epstein Becker & Green PC RAPS San Francisco, CA April 27, 2007. Topics. Overview Where are Combination Products Going? Where is Combination Product Regulation Going?

1.32k views • 58 slides

Efficacy review of allergenic products

553 views • 41 slides

The Dynamic Environment of Laws, Regulations and Policy.

The Dynamic Environment of Laws, Regulations and Policy. Coming to Grips with uncertainty in the process. Richard M. Lewis, PhD Access BIO, LC rlewis@accessbio.com. Or:. What are they thinking? What do they really want? What did they mean by that?. Federal Register.

396 views • 27 slides

Clinical Trials

Clinical Trials. Importance in future therapies. What are the Requirements to Produce New Drugs? Drug must work significantly better than a control treatment

667 views • 25 slides

Center for Professional Advancement Generic Drug Approvals Course

Center for Professional Advancement Generic Drug Approvals Course. Bioequivalence & Bioavailability Michael A. Swit, Esq. Vice President. Definitions. Statutory

371 views • 24 slides

Revisions to 21 CFR 314.70

1.59k views • 19 slides

Chapter 3

Chapter 3. Drug Regulation, Development, Names, and Information. Drug Regulation, Development, Names, and Information. Landmark drug legislation New drug development Drug names Over-the-counter drugs Sources of drug information. Landmark Drug Legislation.

379 views • 18 slides