FDA’s Center for Drug Evaluation & Research: 2016 Priorities
FDA’s Center for Drug Evaluation & Research (CDER) 2016 Priorities & Areas of Focus Front Burner Priorities: Negotiate PDUFA 6 agreements Negotiate GDUFA 2 agreements Negotiate a second BSUFA program...
Woodcock Announces CDER’s 2016 Priorities & Says ANDA Backlog was the Biggest Challenge of GDUFA I
On Monday, December 14th, the director of FDA's Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., spoke at the FDA/CMS Summit for Biopharma Executives where she announced the...
FDA Releases CDER’s 2017 Guidance Agenda
Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...