FDA posts a draft guidance on recommendations for measuring and recording growth, and evaluating pubertal development for evaluating safety in pediatr...
Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.
FDA issues Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults with hepatitis delta v...
Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction o...
Federal Register notice: FDA posts notifications that four information collections have been approved by OMB.
FDA relaxes advertising and promotion restrictions placed on six Covid-19 emergency use authorizations.
FDA posts a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this year.
An FDA advisory committee unanimously votes to not recommend approval of a Y-mAbs Therapeutics BLA for I-omburtamab.
