FDA – Page 8 – Policy & Medicine

FDA Finalizes Guidance to Help Regulated Industries with Voluntary Recalls

FDA Requests Comments on Potential Modification to Opioid Analgesic Risk Evaluation and Mitigation Strategy

FDA Publishes Guidance on Premarket Pathways for Combination Products

FDA Announces Proposed Recommendations for Fifth Reauthorization of Medical Device User Fee Amendments

FDA Plans to Move Forward with Studies on Patient Understanding of Accelerated Approvals

FDA Issues New Set of Guidances Focused on Generic Drug Submissions and Labeling Updates

OPDP Issued Six Letters in 2021

Califf Narrowly Voted by Senate to Be Next FDA Commissioner

OPDP Sends “Bad Ad” Warning Letter over PARAGARD Video

OPDP Sends Warning Letter to CytoDyn Over Promotional Video for Its IND Leronlimab