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This edition of Quick Notes focuses on FDA approvals for expansion of the age allowed for a treatment for muscular dystrophy, an expanded age indication of an RSV vaccine, a next-generation tyrosine kinase inhibitor (TKI) for certain solid tumors, a drug for certain thyroid cancers and an autoinjector for adults with moderate-to-severe atopic dermatitis. Read More
This week, the FDA published a final rule on medical gases. Final guidance was issued on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Final guidance was also issued on drug development for diabetic foot infections, bioanalytical method validation and study samples, clinical pharmacology, and date decisions under GDUFA. Draft guidance was published on demonstrating interchangeability. The agency is also seeking nonvoting industry members for its advisory committees. 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
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
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
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
This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution from Heuron to alert of impending intracranial hemorrhage and clearance of an easy-to-use EEG system from Zeto. 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
This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
This week, the FDA issued a final rules related to the administrative destruction of medical devices that are thought to be counterfeit and announcing the termination of the Science Advisory Board to the National Center for Toxicological Research. Draft guidance was published on the platform technology designation program for drug development. Read More