FDA Policy/General

FDA Seeks Comments on Reducing Regulation Burden

Federal Register multiple notices: As part of the Trump Administration’s “Reducing Regulation and Controlling Regulatory Costs” efforts, FDA is seeking comments to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction while allowing it to achieve its public health mission and fulfill statutory obligations. The multiple notices below ask for comments on each specific FDA regulatory product center and general regulatory and information collection requirements that affect multiple FDA centers or offices:

Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements PDF
Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements PDF
Review of Existing Center for Veterinary Medicine Regulatory and Information Collection Requirements PDF
Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements PDF
Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements PDF
Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements PDF
Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration PDF

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