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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The FDA’s draft guidance on interchangeability describes considerations for switching studies to support a product as interchangeable with a reference product, given the limited risk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
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 rule yielded less than 25 public comments. Read More
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 EU wants to ensure a steady supply of medical radioisotopes and two new Q&A docs — one for biosimilars and one for medical devices that incorporate a medicinal product. Read More
It was a blast from the past for Hybrid Pharmaceuticals, when FDA investigators observed the same corrosion, dust, and poor aseptic technique noted in inspections carried out in 2016, 2019 and 2021. Read More
The FDA initially advised manufacturers that the vaccine for fall 2024 should be monovalent JN.1 vaccines, but after reviewing current data, “along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.” Read More