Delivery Method: VIA UPS Return Receipt Requested Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Venkata R. Gogineni, Ph.D. Recipient Title CEO Seaway Pharma Inc. 5 County […]

Delivery Method: VIA UPS Reference #: 320-26-21 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Luis F Salazar Recipient Title President/CEO CDL Services, Inc. DBA Technichem […]

Delivery Method: Via Electronic Mail – Return Receipt Requested Reference #: 320-26-16 Product: Drugs Recipient: Recipient Name Mr. Randy D. Stevenson Recipient Title President DeVere Manufacturing […]

A sponsor of a nonprescription drug product may seek to market a prescription drug product as nonprescription.  A sponsor of a prescription drug product may initiate […]

Docket Number: FDA-2019-D-5473 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance addresses questions that manufacturers, […]

For Immediate Release: March 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

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

[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional […]

[12/8/2025] The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists […]