For Immediate Release: March 05, 2026 The U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards […]

Submit Comments by 05/04/2026 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 […]

The U.S. Food and Drug Administration (FDA) has approved Yuviwel (navepegritide) for injection to improve growth in pediatric patients aged two years and older with achondroplasia […]

The workshop will be held as a hybrid (in-person and virtual) meeting. Attendees may join in person at the FDA White Oak Campus, 10903 New Hampshire […]

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

On This Page Date: October 5, 2023 Time: 9:30 a.m. – 3:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]

Docket Number: FDA-2024-D-0803 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research ICH Website The Food and Drug […]

Docket Number: FDA-2024-D-2754 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC). The NDC is an FDA standard […]