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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 Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This week, the FDA published final guidance on glass vials and stoppers, OTC monograph submissions and real-world data. Draft guidance was issued on pediatric inflammatory bowel disease and postapproval manufacturing changes to biosimilars. The agency also announced that it is seeking information and comments on biosimilar product development and host cell proteins. Read More
FDA issued a Warning Letter to Criticare Technologies for failure to investigate complaints that its nGenuity patient vital signs monitor — which can be used during surgery — had shut off intermittently. Read More
Jeff Shuren, currently Director of CDRH, has announced that he is leaving the agency after 28 years of service including 15 years as the director. Read More
In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain for the next vaccines and a 483 for Swiss company Lonza. Read More
Guardant Health has agreed to pay $900,000 to settle allegations that it participated in a scheme with a physician to submit charges to Medicare in violation of the False Claims Act. Read More
The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA has issued a final guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing the study, and reporting results. Read More
This week, the FDA published final guidance on drugs for treatment of partial onset seizures, combination product user fees, radiolabeled mass balance study clinical pharmacology considerations. Draft guidance was issued on pediatric inflammatory bowel disease. The agency also announced interactive site tours of biotechnology manufacturing facilities developing cellular and gene therapies. Read More
The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to prevent their enteral syringes from entering the US. Read More
In this edition, we note the release of the EU’s highly anticipated AI Act, new reporting requirements for expected interruptions in the supply of medical devices or diagnostics and new guidance on IVD classifications. Read More