Drugs

Commissioner’s Voucher Program Q&A Published

Faced with mounting criticism of the Commissioner’s National Priority Voucher (CNPV) Pilot Program, focusing on the potential safety risks from quicker reviews, questions about possible politicization and favoritism, legal and transparency concerns, and the strain placed on agency resources and staff, FDA has published a news release with 18 questions and answers about the program. The document emphasizes that CNPV product applications are reviewed by agency primary review teams with the appropriate subject matter expertise.

It says the pilot’s “tumor-board style panel,” now called the CNPV Review Council, does not make drug approval decisions but instead meets with the primary review team to discuss part of an application and make a non-binding recommendation to the relevant Center director on the approvability of that part of the application. “Decisions regarding drug approval remain within the FDA Centers and follow the usual FDA processes,” it says.

The release says the CNPV does not affect existing expedited programs, although it incorporates some of their elements.

FDA lists the documentation already available on the program and says additional documentation, such as a draft guidance for external stakeholders, will be issued in the coming months as the program matures and feedback from internal and external stakeholders is incorporated.

A request for public feedback on the CNPV will appear in a future Federal Register notice that opens a public docket, the agency says, and listening sessions with external stakeholders will be scheduled.

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