Drugs

PDUFA 7 Reauthorization Manufacturing, Digital Health, CBER Meetings

At the 1/13 meeting of the PDUFA 7 reauthorization FDA and Industry Manufacturing Subgroup, the two sides continued discussions around a CMC readiness pilot for certain products. A meeting summary shows that both the agency and industry representatives saw potential benefit in a pilot and discussed the duration of a pilot and potential outputs from it. They discussed the potential for a multi-day workshop during mid-PDUFA 7 to assess the pilot and share lessons learned. The discussion continued at the 1/21 meeting, which also considered alternative tools to assess manufacturing facilities named in pending applications and advanced manufacturing.

At the 1/27 meeting, the parties discussed language and rationale for the timeline of an independent assessment for product quality information requests. Eligibility criteria for the CMC pilot program also were discussed. Much of the meeting was focused on reviewing industry edits to draft commitment language. Review of the edits continued at the 2/3 meeting.

At the Digital Health and Informatics 1/13 meeting, the parties discussed the data/IT modernization proposal and discussed commitment language, resources, and alignment on key priority areas. The discussion continued at the 1/22 meeting and the 1/27 meeting. At the 2/1 meeting, the parties reached an agreement on the remaining issues and commitment language relating to digital health technology and data/IT modernization. The parties agreed that FDA would report milestones and metrics throughout modernization as it develops its strategy, with inputs from industry at the annual joint meeting outlined in the commitment.

The CBER Breakout Group 1/12 meeting focused on resource estimates for the CBER and industry proposals related to the cell and gene therapy program. The discussion continued with resource estimates at the 1/26 meeting.

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