Drugs

Several Topics in Ongoing PDUFA Reauthorization Negotiations

PDUFA reauthorization discussions were held by various committees, working groups, and subgroups in five sessions held virtually in October and November 20. Meeting summaries and minutes for each session were released by FDA and show:

FDA/Industry Postmarket Subgroup, 10/28/20 — continued discussions of possible options of common interest between the two sides on Sentinel and REMS. Industry presented initiatives intended to enhance Sentinel analytic capabilities. They will be reviewed by subject-matter experts in the agency and industry.
Manufacturing and Inspections Workgroup, 10/28/20 — Discussion focused on exploring the industry’s PDUFA 7 manufacturing and inspection topics. Industry representatives expressed interest in leveraging lessons learned and best practices between CDER’s emerging technology team program and CBER’s advanced technology teams program. Industry described a framework between the two programs that it said would enhance efficiency, regulatory predictability, and consistency. The two sides also discussed perspectives on prior approval manufacturing supplements.
FDA and Industry Finance Subgroup, 10/28/20 — Topics discussed were performance reporting proposals, resource capacity planning, and health of the workforce proposal.
Manufacturing and Inspections Workgroup, 11/4/20—The meeting focused on reviewing the status of all proposals and identifying areas of agreement and areas that need more discussion. The two sides tentatively agreed to enhancements to information requests and mid-cycle communications.
FDA and Industry Negotiation Steering Committee, 11/10/20 — There were high-level updates on regulatory decision tools, CBER breakout, digital health and informatics, finance, post-market, pre-market, and CMC and inspections. Following the high-level updates, there was a discussion on resource tabulation and public stakeholder meetings.

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