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Deadlines Food and Drug Administration (FDA) Pharmaceutical Industry

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

DLA Piper

Certain DSCSA Deadline Extensions Set to Eclipse in 2025

DLA Piper on

The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics...

The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more

Arnall Golden Gregory LLP

Are You Ready for OTC Drug Reform? The 180 Day Deadline is Fast-Approaching

The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to the Food and Drug Administration’s regulation of over-the-counter (OTC) drugs in the United States.  We previously...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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