Biologics

FDA Yanks Notice Seeking OMB Approval on Biologic Naming

FDA has withdrawn a 6/2-published Federal Register notice that sought Office of Management and Budget approval on an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the nonproprietary name on such products (see story). According to the FDA notice on the guidance, applicants should submit up to 10 proposed suffixes, in the order of the applicant’s preference. It also recommends including supporting analyses demonstrating that the proposed suffixes meet the factors described in the guidance for FDA’s consideration.

OMB approval was the next step in the guidance process, and the FDA withdrawal comes as a surprise. An FDA spokesman told FDA Webview earlier this month that final guidance is “forthcoming,” but no specifics on the timing were provided. Now, the spokesman says that the “publication of the notice was an administrative error. FDA continues to review comments and work on a final guidance.”

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