Drugs

FDA Complex Innovative Designs Meeting Praised

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the goal of an FDA public meeting to facilitate a discussion of the use of external data sources, Bayesian statistical methods, and modeling and simulation supporting clinical trial complex innovative designs (CIDs), and to explore examples of how CIDs are implemented in practice. The meeting fulfilled an agency PDUFA 7 commitment.

The association’s comment letter says PhRMA also supports the continuation of the CID Paired Meeting Program under PDUFA 7 that started as a PDUFA 6 pilot. It says the program “offers FDA and sponsors a collaborative mechanism to better understand the utilization of a variety of innovative trial designs, adopt appropriate simulation methods, and gain the experience needed to support the use of CIDs in regulatory decision-making.” The letter also provides the association’s general and specific comments on the meeting.

In its response, Novartis says it supports FDA’s efforts to engage stakeholders to explore the learnings from the CID pilot program and consider how to put novel approaches into practice to advance medical product research and development. “When conducted with careful consideration, sufficient scientific rigor, and under the appropriate clinical circumstances, CIDs may offer certain advantages to traditional approaches and inform regulatory decision-making,” Novartis says. It provides detailed statistical comments and answers to questions posed by FDA.

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