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The FTC submitted a comment supporting a proposed US Patent and Trademark Office (USPTO) rule to address patent system abuse such as the creation of overlapping patent rights known as patent thickets, which can block or delay competition, a problem especially apparent in bringing generics and biosimilar drugs to market. Read More
This edition of Quick Notes looks at FDA approvals and clearances for devices involving digital pathology images, implantable device protective pockets, and measurement/monitoring systems for obstetrical and cardiac care. Read More
The potential for radiofrequency coils heating up during an MRI scan has led the FDA to deem Philips’ recall of its Sense XL Torso Coils as Class I, as overheating could cause thermal injury. Read More
To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA), a risk management tool that supports the HF engineering process. 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
Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will comply with the US Supreme Court’s new decision on who ultimately is in charge of interpreting federal regulations — federal agencies or the courts and Congress. Read More
This week, the FDA published a draft guidance on drug delivery outputs for devices used to deliver drugs and general principles on plan, design, and analysis of pharmacoepidemiological studies. Read More