A part of an anesthesia system from Getinge that may dispense toxic gas and a cardiac balloon catheter from Teleflex/Arrow that may overtwist during use are both the subject of…
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…
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…
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. Source: Drug Industry Daily
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…
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…
The FDA has established an Artificial Intelligence Program with a focus on six research topics that delve into the far-reaching implications of medical devices powered by AI and machine learning.…
The House’s fiscal 2025 Agriculture-FDA bill, released Monday, keeps spending almost flat, providing the FDA with $6.75 billion in total funding, short of the agency’s $7.2 billion budget request. Source:…
The FDA has deemed two recalls as Class I — Medline Industries for issues with its Sub-G Endotracheal Tube and Abbott for yet another issue with its HeartMate 3 Left…
Alzheimer’s drugmakers including Biogen, Eli Lilly and Eisai, as well as consumer advocacy group Public Citizen, have characterized a recent FDA guidance on developing drugs for Alzheimer’s as lacking in…