FDA Policy/General

Info Sought on Supply Chain Security

Federal Register notice: FDA is requesting information to better understand the status of trading partners’ (manufacturers, wholesale distributors, dispensers, and repackagers) interoperable systems and processes for enhanced drug distribution security. The agency says that trading partners should be using the current stabilization period to continue to build and validate secure, interoperable, electronic systems and processes, and it seeks information to confirm their progress on implementing Drug Supply Chain Security Act requirements for enhanced drug distribution security. Information sought includes (1) Are trading partners using the stabilization period to troubleshoot and mature secure, electronic, interoperable systems and processes for enhanced drug distribution security with upstream trading partners? (2) What are the most significant challenges trading partners have overcome? (3) What aspects of the systems and processes have trading partners successfully operationalized? (4) What are the next steps to ensure successful implementation of the enhanced drug distribution security requirements by 11/27/2024? To view the notice, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome