Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Hale N. Dimetry Recipient Title President PQ Pharmacy, LLC 15215 […]

Delivery Method: Via Electronic Mail – Return Receipt Requested Reference #: 320-26-17 Product: Drugs Recipient: Recipient Name Mr. Glen S. Putnam Recipient Title Senior Director of […]

Docket Number: FDA-2023-D-2439 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]

Docket Number: FDA-2025-D-4634 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

For Immediate Release: May 11, 2023 Español Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the […]

Submit Comments by 01/30/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Submit Comments by 01/30/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Docket Number: FDA-2025-D-4678 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

Docket Number: FDA-2025-D-4678 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]