FDA

FDA Extends Drug Use Dates Due to Shortages

The FDA has extended the use dates for specific lots of certain drugs to help alleviate drug shortages. This guidance allows providers and patients to use these lots beyond their labeled expiration dates, based on manufacturer stability data. The agency is not requiring relabeling but expects replacement and disposal when new product becomes available.

FDA Drug Shortage Update

The FDA has updated its list of current and resolved drug shortages. The notice indicates 56 drugs are currently in shortage, 45 have been resolved, and 11 have been discontinued. This update provides a snapshot of the ongoing drug supply situation.

FDA Report on Drug Shortage Prevention Efforts

The FDA has released its annual report to Congress detailing efforts in calendar year 2024 to prevent and mitigate drug shortages. The report highlights successful interventions that prevented 283 potential shortages, with only 15 new shortages identified.

FDA Novel Drug Approvals in 2022

The FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs in 2022, including new molecular entities (NMEs) and new therapeutic biological products (BLAs). This notice summarizes these approvals and provides a link to the full report.

FDA Novel Drug Approvals in 2023

The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.

FDA Novel Drug Approvals 2025

The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.

FDA Approves 5 New Novel Drugs in 2026

The FDA has announced the approval of five new novel drugs in 2026 for various medical conditions. These approvals include treatments for achondroplasia, hyperarginemia, schizophrenia, bipolar disorder, atopic dermatitis, and Menkes disease. The agency updated its list of novel drug therapy approvals.

FDA Novel Drug Approvals 2024

The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.

FDA Guidance on Medical Devices for Weight Loss

The FDA has issued guidance for medical devices intended for weight loss, outlining recommendations for non-clinical testing and clinical study design to support premarket submissions. This guidance aims to promote consistency and facilitate efficient review of submissions for devices related to weight loss, reduction, management, or obesity treatment.

FDA Warning Letter to Rio Verde Food Service Inc.

The FDA issued a warning letter to Rio Verde Food Service Inc. on February 27, 2026, citing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation following an inspection in July 2025. The company's HACCP plan for Live Oysters was found to be inadequate in controlling critical limits for temperature during receiving and storage, and its corrective action plans were insufficient.