Pfizer says it will stop enrolling standard risk patients in the EPIC-SR trial of its anti-Covid therapy Paxlovid and submit data to FDA in an NDA.
The Senate Health, Education, Labor and Pensions Committee passes the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the agency...
Federal Register notice: FDA makes available a draft guidance for industry entitled Q9(R1) Quality Risk Management (QRM).
CDER director Patrizia Cavazzoni tells FDLI she is personally spearheading the Centers new rare disease efforts to speed and increase the development ...
FDA publishes a draft guidance on the voluntary consensus standards recognition program for regenerative medicine therapies.
FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes to recommend the agency expand the Covid-19 emergency use authoriza...
FDA publishes a guidance with recommendations for manufacturers on information to go in premarket submissions for radiological devices with quantitati...
The Alliance for a Stronger FDA says it supports the FDA funding proposed by a House Agriculture Appropriations subcommittee.