Drugs

Suggestions for FDA Adaptive Design Draft Guidance

Janssen says an FDA draft guidance on adaptive designs for clinical trials of drugs and biologics “provides clear expectations for planning and implementation of adaptive designs in clinical trials.” The company says it believes the guidance will facilitate wider use of the innovative and more efficient designs in drug development. It also provides specific line-by-line comments it believes will enhance the document’s usability.

The Biotechnology Innovation Organization says the draft is “well written and provides important information to allow companies to use adaptive trial designs…. The draft guidance would benefit from additional discussion as to the feasibility to trigger early submission based on reaching the primary efficacy endpoint, while also having additional enrollment and/or follow-up to generate the requisite amount of safety data.” Specific line-by-line comments are included in the letter.

The Association of Clinical Research Organizations “congratulates FDA on producing a detailed, comprehensive, and helpful draft guidance on adaptive designs for clinical trials and biologics.” The comment letter contains both general comments and a small number of specific comments on the text.

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