The war against fake GLP-1 inhibitors is heating up, with Eli Lilly filing six suits against med spas and wellness centers selling unapproved versions of its patented tirzepatides — Mounjaro…
An inspection of the Dr. Reddy’s Laboratories Andra Pradesh, India, facility two weeks ago brought the company yet another Form 483, this time for a lack of valid testing, failure…
This edition of Quick Notes focuses on FDA approvals for expansion of the age allowed for a treatment for muscular dystrophy, an expanded age indication of an RSV vaccine, a…
This week, the FDA published a final rule on medical gases. Final guidance was issued on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Final…
The FDA’s draft guidance on real world evidence (RWE) for non-interventional studies is too high level and lacks enough detail to guide the drug and biologics industry which limit its…
Intensive sessions of behavioral modification — not weight loss drugs — are the best way to treat children and teens who are overweight or obese, according to new treatment recommendations…
The FTC submitted comment supporting the US Patent and Trademark Office (USPTO) April proposed rule that seeks a variety of changes to the Patent Trial and Appeal Board (PTAB) proceedings…
The FDA’s draft guidance on interchangeability describes considerations for switching studies to support a product as interchangeable with a reference product, given the limited risk the FDA has seen in…
Government spending on the 340B Drug Pricing Program rose almost 20 percent per year from 2010 to 2021, spiking from $6.6 billion to $43.9 billion, with 88 percent of the…
Warning letters to FDA-registered drug manufacturing sites rose in 2023 while product recalls declined, recent trends that represent a sampling of CDER’s data-laden “2023 Report on the State of Pharmaceutical…