Without enough staff at the CDER, which receives user fees ... not replace them," according to a Congressional Research Service document (PDF) explaining the program. With this in mind, the ...

The former CDER leader will succeed Aida Habtezion, M.D., who served as Pfizer’s CMO and head of worldwide medical and safety for four years, and will be leaving the pharma to "pursue other ...

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference ...

The software program was acquired and used under Research Collaboration Agreements between FDA/CDER and the software provider. All training set structures were imported into LS and fingerprinted using ...