FDA Policy/General

Science Board to Review Cure Act Work Plan

FDA is seeking comments from its Science Board on a draft work plan on 21st Century Cures Act Innovation Account Activities that prioritizes patient-focused drug development and qualification of drug development tools when monies are appropriated by Congress. The draft discusses how FDA is required under Cures to establish a qualification process for drug development tools (e.g., biomarkers, clinical outcome assessments) for proposed contexts of use. “Once a drug development tool is qualified under this new process, any sponsor may use it for its qualified context of use to support an application for approval or licensure of a drug or to support the investigational use of a drug,” the agency says. “Expert FDA staff and contractors will help develop evidentiary criteria needed to support qualification, develop regulatory informatics platforms, and integrate new review processes. This must occur quickly to ensure FDA can meet its obligations under this section within statutory timeframes, including developing and issuing guidance outlining procedures for the qualification process, holding public meetings, and posting public reports. Once fully implemented, this section has the potential to transform drug development and review.”

Additionally, the draft emphasizes FDA’s role in helping sponsors incorporate complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs and biological products in order to facilitate more efficient product development. “To accomplish this FDA must hold a public meeting 18 months after the date of enactment of the Cures Act and issue guidance on, among other things, how to use such novel trial designs, how they can help to satisfy the substantial evidence standard, and recommended analysis methodologies,” the work plan says.

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