FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.
FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are being manufactured with...
Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secretary Robert F. Kenn...
FDA publishes two guidances relating to the CDRH/CBER Q-submission process.
GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...
CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals already in 2025.
In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault against the pharmaceutical industry and direct-to-consum...
Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regulate prescription dru...
