For Immediate Release: July 07, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Image Español People are seeking treatments to smooth smile lines and crow’s feet and plump up their lips, cheeks, and hands.  Injecting dermal fillers into the face […]

About FDA Guidances Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any […]

Summary Company Announcement Date: July 06, 2023 FDA Publish Date: July 07, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Failure to deliver the […]

For Immediate Release: July 06, 2023 Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional […]

Frequently Asked Questions (FAQs) What is the right time for a drug developer/sponsor to apply for MIDD? MIDD approaches can add value throughout drug development; therefore, […]

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 […]