Drugs

CID Guidance, MAPPs Coming: Price

CDER Division of Biometrics IV director Dionne Price says FDA will publish draft guidances and develop or revise relevant Manuals of Policies and Procedures, standard operating procedures, and/or review templates to support increasing use of complex innovative trial designs (CIDs). In a CDER Conversation, Price says the guidances will address several areas related to CIDs, including use of complex adaptive clinical trial designs, best practices for conducting simulations, submission of resulting information, the types of quantitative information that should be submitted for review, and recommended analysis methodologies.

She also says that to facilitate appropriate use of CID methods, FDA will develop staff capacity to support the computationally intensive review work necessary to evaluate such designs and analyses.

Under a CID pilot meeting program, Price writes, sponsors will have the opportunity to submit meeting requests on a rolling basis, and FDA will select up to two requests per quarter over a five-year period. Sponsors who are selected will participate in an initial and follow-up meeting with regulatory staff to discuss how the proposed CID approach may be used in their drug development program. Statistical staff in CDER or CBER will lead the meetings, she says, and they will include additional relevant expertise from across the agency. FDA may then use elements of the clinical trial design as a case study for continuing education and information-sharing.

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