FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Products Q1.
A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citations.
FDA approves a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for certain adults with locally advanced or metastatic epidermal growth f...
Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety r...
Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling research-use-only (RUO) di...
FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological material, including DNA, ...
FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the latest shake-up at ...
The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advanced manufacturing is...
