The FDA, which started 2022, on a slow note, has so far approved 30 novel drugs, compared to 47 that were approved during the same period last year. Now, let s take a look at the biotech stocks facing FDA decision in December.
Food and Drug Administration FDA user fee programs pay the salaries of agency staff review drug and medical device applications set to expire. Prescription Drug User Fee Act PDUFA, Generic Drug User Fee Amendments GDUFA, Biosimilar User Fee Act BsUFA, Medical Device User Fee Amendments MDUFA.
Relief Therapeutics Holding SA / Key word(s): Regulatory Approval Relief Reports that its Collaboration Partner, Acer Therapeutics, Issued a Statement Regarding the PDUFA Target Action Date for ACER-001
On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency.
PDUFA target action date of November 17, 2022SAN DIEGO, May 16, 2022 Travere Therapeutics, Inc. today announced the U.S. Food and Drug Administration has accepted and granted Priority Review. | May 16, 2022