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Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.[ Price : $8.95]
FDA issues Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults wi...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Tr...[ Price : $8.95]
Federal Register notice: FDA posts notifications that four information collections have been approved by OMB.[ Price : $8.95]
FDA relaxes advertising and promotion restrictions placed on six Covid-19 emergency use authorizations.[ Price : $8.95]
FDA posts a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this ...[ Price : $8.95]
An FDA advisory committee unanimously votes to not recommend approval of a Y-mAbs Therapeutics BLA for I-omburtamab.[ Price : $8.95]
FDA clears a Fresenius Medical 510(k) to implement changes to its 2008T hemodialysis machines that addresses an earlier FDA safety...