July 6, 2018

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Recent Posts

FDA Comments on Recently Released Rare Disease Guidance for Industry

September 16, 2015

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...

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Featured Posts

FDA Case Study - Drug Approval: Bringing a New Drug to the Market

October 28, 2015

FDA is introducing a new learning tool for patients and patient advocacy groups, health professionals, small business, and pharmaceutical and clinical innovators designed to advance knowledge of drug regulatory processes. 


The first case study, Drug Approval: Bringing a New Drug to the Market, is a detailed and engaging learning experience on how to navigate the drug approval process from conducting nonclinical testing and clinical trials to submitting a new drug application to FDA.


For more information and access to the first case study, please visit the link below.



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