FDA posts a guidance entitled FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Bio...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance on Oxymetazoline Hydrochloride.
CDER Office of Surveillance and Epidemiology director Gerald J. Dal Pan says FDA is developing new tools to help identify drug postmarket safety issue...
FDA clears a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump with Dose IQ safety software.
FDA approves AstraZenecas Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating extravascular hemol...
Eisai files a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimers disease patients.
FDA posts a final guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.
Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports.
