Drugs

FDA Denies AbbVie Interchangeability Petition

FDA has denied an AbbVie 12/17/15 petition asking the agency to ensure that applicants seeking interchangeability determinations meet the “Safety Standards for Determining Interchangeability” in the Public Health Service Act for each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label its product for each condition of use. The company also asked FDA to “clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity.” Its final request was that the agency convene a hearing to obtain public input on the topic and then issue guidance or regulations to address the issue.

The denial letter notes that FDA published 1/17 a draft guidance on considerations in demonstrating interchangeability with a reference product. “We encourage AbbVie to participate in FDA’s guidance development process by reviewing the guidance and submitting any comments to the public docket…,” it says. The agency says it intends to consider issues related to interchangeability in the context of the public document and does not intend to hold a public hearing or meeting on the draft guidance.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