Drugs

FDA/Industry PDUFA 7 Discussions Updated

At the 10/13 meeting of the PDUFA 7 FDA and the industry negotiation regulatory decision tools subgroup, FDA discussed the Complex Innovative Trial Design (CID) program and its PDUFA 6 pilot. A meeting summary says FDA discussed a need to build upon the current pilot to provide time, expertise, and resources to progress toward full implementation of the appropriate use of CIDs.

The summary says industry asked questions related to the current CID pilot, including the current resource and staffing allocations and workload. Industry also asked questions about pain points of the CID program. Industry representatives presented their proposal related to CID.

At the 10/14 manufacturing and inspections workgroup meeting, participants explored industry’s PDUFA 7 manufacturing interests related to pre-market content. Industry proposals centered on accelerated chemistry, manufacturing, and controls (CMC) review and clarification on the CMC content expected to be in a regulatory application for expedited pathway products. The two sides agreed that discussions on the issue would continue in the future.

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

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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