Major amendments are replacing complete response letters when FDA has a problem with an NDA.
FDA's outstanding review efficiency under the PDUFA V review program is made possible in part by frequent use of major amendments, analysis of Center for Drug Evaluation and Research approvals of new molecular entities and novel biologics shows.
CDER approved 45 novel agents in 2015, a 19-year high. The first-cycle approval rate of 87% is also a historic high, topping the previous high mark of 78% set in...
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
