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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 recalls that the FDA has deemed as Class I, the most serious recall as use of the devices may result in injury or death. 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
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
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. Read More
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. Read More
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 Ventricular Assist System. Read More
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 specifics for later-stage disease progression. Read More
AdvaMed notched a victory last Friday when the US Court of Appeals ruled in its favor in the latest saga over what the association describes as preventing “unauthorized and unregulated repair companies from hacking into life-saving medical devices.” Read More
A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version. Read More