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…
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…
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…
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…
The FDA has finalized two draft documents that provide guidance for sponsors developing and testing oligonucleotides, and drugs to treat diabetic foot infections without bone or joint involvement. Source: Drug…