FDA Policy/General

Latest Federal Register Notices

FDA GENERAL

Comments Sought on Advisory Panel New Member Nominations
Federal Register Notice: FDA is seeking comments on a new information collection under its “Process for Collecting Nominations of Candidates to Serve on FDA’s Advisory Committees.” In order to identify and select qualified individuals to serve on its advisory committees, FDA has established an online portal, the FDA Advisory Committee Membership Application, to accept nominations of potential advisory committee members. The portal is designed to accept applications for academician/practitioner, consumer representative, and industry representative membership types. To submit a nomination application, prospective nominees should upload the following documents: (1) curriculum vitae; (2) a written confirmation that the nominee is aware of the nomination (unless self-nominated); and (3) letters of recommendation. To view the notice, click here.

Unredacted CVs for Advisory Panel Members to be Posted
Federal Register Notice: FDA is modifying the process by which it collects and post curricula vitae (CVs) of advisory committee members. The new process requires FDA to post CVs to its Web site without removing or redacting any information. Posting CVs without removing or redacting any information will increase panel member selection transparency, and will ensure greater public access to their qualifications. Because advisory committee members are best situated to determine whether there is confidential information in their CVs, the modified collection and posting process will conserve FDA resources as they are removed from such redacting. To view the notice, click here.

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