Submit Comments by 09/01/2025 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 […]

FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, […]

Docket Number: FDA-2022-D-2301 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-01 Product: Drugs Recipient: Recipient Name Peter Michael, M.D. “Peter Michael, M.D. 1401 East 4th […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-80 Product: Drugs Recipient: Recipient Name Mr. Luv Patel Recipient Title Owner Healwell Homeo Private Limited Plot No. 215/1 […]

Product: Drugs Recipient: www.buynetmeds.com India Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.buynetmeds.com FROM: The United States Food and Drug Administration […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-01 Product: Drugs Recipient: Recipient Name Peter Michael, M.D. Peter Michael, M.D./G+C Research Group 1401 […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Lyndon R. Leitner Recipient Title CEO Staska Pharmaceuticals, Inc. 742 […]

Through Pediatric Research Equity Act (PREA) postmarketing requirements (PMR), FDA required drug sponsors to evaluate pharmacokinetics (PK), efficacy, and safety of extended-release stimulants in children 4 […]