Docket Number: FDA-2012-D-0315 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance defines the recommended format […]

Summary Company Announcement Date: March 26, 2020 FDA Publish Date: March 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Ampules breaking & shattering […]

What we do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]

On This Page Date: October 28, 2022 Time: 10:00 AM – 3:00 PM ET UPDATED INFORMATION (as of 10/13/2022): The meeting agenda has been updated to […]

Docket Number: FDA-2018-D-3984 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research, Office of […]

Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is contaminated with […]

Summary Company Announcement Date: December 22, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Visible Glass […]

Reference #: WL 2310 Product: Drugs Recipient: Recipient Name Peter Levasseur Unit Dose Services, LLC 20201 Northeast 16th PlaceMiami, FL 33179United States Issuing Office: Center for […]

Reference #: WL 2277 Product: Drugs Recipient: Recipient Name Elizabeth Hanlon Rite Aid Corporation 200 Newberry CommonsEtters, PA 17319United States Issuing Office: Center for Drug Evaluation […]