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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
In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of its guideline on the clinical evaluation of anticancer medicinal products. Read More
During its second town hall on reducing the use of ethylene oxide (EtO) to sterilize medical devices, FDA officials announced the creation of a dedicated EtO “tiger team” with expertise in regulatory science, regulatory review, policy, supply chain, and incident response. Read More
In a move that caught many industry experts unaware, the U.S. government last week announced the sale of the Federal Helium Reserve to a private company, despite warnings about the risk of shortage for critical helium that powers magnetic resonance imaging (MRI) machines. Read More
Philips Respironics announced that it has agreed to the terms of a consent decree which will require it to cease the sale of new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S. Read More
The FDA has revised a previous draft on its current approach to conducting remote regulatory assessments (RRA), incorporating public comments as well as recent amendments to the Food, Drug and Cosmetic Act. Read More
Over the past week, the FDA issued final guidance on revising ANDA labeling, draft guidances on metallic coatings and/or calcium phosphate coatings on orthopedic devices and conducting remote regulatory assessments. The agency also announced a meeting of the circulatory system devices panel of the medical devices advisory committee and posted best practices for FDA staff in postmarketing safety surveillance. Read More
In the face of inveterate manufacturer foot-dragging and a dearth of certified review bodies, the European Commission (EC) is once again proposing to extend the deadline for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). Read More