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Today's Popular Updates › Federal Food Drug and Cosmetic Act (FFDCA) › Supply Shortages

A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Harris Beach Murtha PLLC

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

Harris Beach Murtha PLLC on

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

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

Fuerst Ittleman David & Joseph on

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Foley & Lardner LLP

GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List

Foley & Lardner LLP on

On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more

Pillsbury Winthrop Shaw Pittman LLP

FDA Regulatory Approvals as the U.S. Emerges from the Immediate COVID-19 Emergency

Pillsbury Winthrop Shaw Pittman LLP on

Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more

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