Apellis Pharmaceuticals says it plans to file an NDA in the first half of 2022 after reporting top-line results from the Phase 3 DERBY and OAKS studie...
YourBio Health names former FDA commissioner Stephen Hahn as its interim chief medical officer.
Federal Register notice: FDA seeks nominations for members to serve on the Tobacco Products Scientific Advisory Committee.
Federal Register notice: CDER announces its Novel Excipient Review Pilot Program and seeks initial proposals by 12/7.
Azurity Pharmaceuticals recalls one lot of Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL kit because some products in the affected lot...
CDER researchers say that more research is needed to determine the most appropriate approaches for statistical and analytical methodologies for patien...
FDAs Medical Device Single Audit Program issues a guideline on a five-level nonconformity grading system for medical devices.
The 13th Annual Sentinel Initiative Virtual Public Workshop 11/8-9 features a keynote address from CDER director Patrizia Cavazzoni.