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A report by Spotlight on America suggests FDA is increasing scrutiny over CooperSurgical and its manufacturing facility in North T...[ Price : $8.95]
FDA posts a guidance entitled FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Repo...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance on Oxymetazoline Hydrochloride.[ Price : $8.95]
CDER Office of Surveillance and Epidemiology director Gerald J. Dal Pan says FDA is developing new tools to help identify drug pos...[ Price : $8.95]
FDA clears a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump with Dose IQ safety software.[ Price : $8.95]
FDA approves AstraZenecas Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating...[ Price : $8.95]
Eisai files a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimers disease patients....[ Price : $8.95]
FDA posts a final guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.