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

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

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. Read More

Over seven hours of presentations, 50 stakeholders and members of the public voiced their opinions on the FDA’s advisory committee process, focusing often on diversity as well as patient and consumer perspectives in the panels, along with improved transparency and communications. Read More

The FDA is issuing exemptions from certain requirements of the Drug Supply Chain Security Act (DSCSA) to small dispensers such as pharmacies until Nov. 27, 2026. Read More

Due to a combination of confounding factors in the regulatory system and the market, patients in Europe wait an average of 531 days to access new medicines, according to three new reports published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) this week. Read More

The US Supreme Court tossed out a challenge to the FDA’s approval of the use of the abortion drug mifepristone (Mifeprex), ruling that the plaintiffs did not have standing to bring the action. Read More