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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 Draft guidance was published on demonstrating interchangeability.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The FDA’s draft guidance on real world evidence (RWE) for non-interventional studies is too high level and lacks enough detail to guide the drug and biologics industry which limit its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The FDA’s draft guidance on interchangeability describes considerations for switching studies to support a product as interchangeable with a reference product, given the limited risk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
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 growth attributed to hospitals and their affiliated off-site clinics, not federal grantees, says a report from the Congressional Budget Office (CBO). Read More
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 Quality” released last week. Read More
The FDA’s push to add three additional categories to its 503A list of demonstrably-difficult-to-compound (DDC) drugs is a thinly veiled effort to further restrict compounding in general, the National Community Pharmacists Association (NCPA) said in a comment opposing the proposal. Read More
The FDA has issued a guidance on how the agency intends to assign a goal date based on a facility’s readiness for inspection when submitted as part of an original ANDA. Read More