Drugs

USP Proposal on Biologicals Concerns FDA

FDA is calling on the United States Pharmacopeia (USP) to withdraw a proposed revision to the General Notices and Requirements relating to USP drug product monographs for biological products. In a comment letter, the agency says it is “concerned that efforts to develop biological product monographs could impede or delay licensure of biosimilars and other biological products.”

The agency says it appears that the USP-proposed revisions do not provide the flexibility needed to support innovation in product development. “FDA’s ongoing concerns about biological product monographs are focused on the possibility that a sponsor of a proposed biosimilar or interchangeable product could be deterred from seeking licensure under the abbreviated pathway Congress created in the Biologics Price Competition and Innovation Act, which does not require the biosimilar applicant ‘to demonstrate that its product contains the same drug substance as the reference product, evaluated using the same tests and assays. USP’s approach could complicate licensure of a biosimilar that meets the approval requirements … but that does not match the standards in the USP monograph associated with the reference product.”

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