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.
FDA makes three revisions to a guidance containing questions and answers on developing ANDAs during the Covid-19 pandemic.
FDA and the Duke-Margolis Center for Health Policy schedule a public meeting on the agencys plan to reconsider the need for mandatory opioid prescribe...
FDA clears a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion procedures.