Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Delivery Method: Via Electronic Mail Return Confirmation Requested Product: Drugs Recipient: Recipient Name Matt McDonald Recipient Title Owner Triad Rx, Inc. 26258 Pollard Rd.Daphne, AL 36526-4250United […]

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Generic products containing bictegravir, emtricitabine, and tenofovir alafenamide Weight increased FDA is evaluating the need for regulatory action. Braftovi (encorafenib) […]

Delivery Method: Via Overnight Delivery Product: Dietary SupplementsDrugs Recipient: Recipient Name Diane R. Becker North Carolina Hemp Exchange, LLC dba NC Hemp Shoppe 6030 Creedmoor Rd. […]

Reference #: WL – 2575 Product: Drugs Recipient: Recipient Name Ho Dong Yang Lydia Co. Ltd. 102 Dongguk-roIlsandong-guGoyang-siGyeonggi-do10325South Korea [email protected] Issuing Office: Center for Drug Evaluation […]

Summary Company Announcement Date: October 01, 2021 FDA Publish Date: October 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company […]

Summary Company Announcement Date: March 29, 2022 FDA Publish Date: March 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Particulate Matter (silica […]

For Immediate Release: June 30, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]