FDA Comments on Recently Released Rare Disease Guidance for Industry
Jonathan Goldsmith, M.D., F.A.C.P., FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, comments on the recently released draft guidance for industry on rare disease drug development. Given the complexity and challenges of developing and bringing to market new FDA-approved drugs to treat rare diseases, we're excited to see this topic garnering more support. Read more here: http://blogs.fda.gov/fdavoice/index.php/2015/09/another-tool-help
Toxicologist Gary Wolfe, PhD, DABT joins Patagonia's Advisory Board
We are pleased to welcome Dr. Gary Wolfe to our Advisory Board. Dr. Wolfe is a board-certified toxicologist with over 35 years of experience in the conduct of nonclinical toxicology studies, director of nonclinical laboratories, and preparation of regulatory submissions and documents. He received his M.S. and Ph.D. in pharmacology and toxicology from Purdue University in 1976 and 1978, respectively. He is a member of the Society of Toxicology, American College of Toxicolog
Biotech Primer's Drug Development Immersion
Patagonia will attend Biotech Primer's Drug Development Immersion course in West Windsor, NJ from February 11-12. Please reach out to us if you would like to connect. #drugdevelopment #biotech #fda #orphandrugs #patagonia
