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's CDER Announces New & Revised Draft Guidances it Plans to Publish in 2016
On Friday, January 22, FDA’s Center for Drug Evaluation and Research (CDER) published its 2016 guidance agenda. The guidance agenda is published on an annual basis and announces the draft guidances...