FDA Policy/General

Temporary Embargo on FDA Communications

The Trump Administration has placed FDA and other government health agencies under an external communications embargo until 2/1. The move, which previous administrations have also ordered in their early transition days, reportedly gives the agencies time for the new political appointees to set up their review and approval of information communicated to the public.

The order to freeze public communications applies to guidance documents, Federal Register notices, regulations, announcements, presentations, press releases, social media posts and Web site posts, according to an HHS memo obtained by the Associated Press.

Meanwhile, HHS secretary-nominee Robert F. Kennedy Jr.’s confirmation hearing date is set for 1/29 after getting bogged down due to an Office of Government Ethics review of his financial disclosure forms and whether they reveal any conflicts of interest. FDA commissioner-nominee and Johns Hopkins surgeon Marty Makary’s confirmation hearing will likely be held after RFK Jr. faces his Senate grilling.

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