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As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject Friday. Read More
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 and Zepbound — with WHO and National Association of Boards of Pharmacy (NABP) also issuing alerts on the problem. Read More
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 to investigate out of specification (OOS) batches and inadequate control in manufacturing active pharmaceutical ingredients (API). Read More
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 next-generation tyrosine kinase inhibitor (TKI) for certain solid tumors, a drug for certain thyroid cancers and an autoinjector for adults with moderate-to-severe atopic dermatitis. Read More
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 guidance was also issued on drug development for diabetic foot infections, bioanalytical method validation and study samples, clinical pharmacology, and date decisions under GDUFA. Draft guidance was published on demonstrating interchangeability. The agency is also seeking nonvoting industry members for its advisory committees. Read More
The FDA’s draft guidance on real world evidence (RWE) for non-interventional studies is too high level and lacks enough detail to guide the drug and biologics industry which limit its usefulness, say stakeholders who commented on the draft. Read More
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 issued by the United States Preventive Services Task Force (USPSTF). Read More
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 including when patent settlement agreements must be disclosed. Read More
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 switching between biosimilars and the reference product. Read More