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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
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 and regulations that could impact your business. 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
This week, the FDA requested information and comments on enhanced drug distribution security requirements. The agency is also seeking nominations for its advisory committees and has amended the OTC monograph for analgesic, antipyretic and antirheumatic drugs. Read More
This edition of Quick Notes focuses on FDA drug approvals of Farxiga for children with type 2 diabetes, Rytelo for myelodysplastic telomerase, Klisyri expanded for actinic keratosis, and Iqirvo for primary biliary cholangitis. Read More