Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and...more
On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more