The FDA’s draft guidance on real world evidence (RWE) for non-interventional studies is too high level and lacks enough detail to guide the drug and biologics industry which limit its…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The FDA’s draft guidance on interchangeability describes considerations for switching studies to support a product as interchangeable with a reference product, given the limited risk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…
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…
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…
The FDA has issued a final rule amending requirements concerning current good manufacturing practice (cGMP), postmarketing safety reporting, labeling and certification of certain medical gases, two years after its proposed…
In this issue of Quick Notes, we provide an eyebrow-raising peek at the European Medicines Agency’s newly announced 2025 marketing authorization fees as well as some insight on how the…