Drugs

FDA Issues Insulin Transition Final Rule

FDA has issued a final rule and question and answers for patients and healthcare providers to ensure a smooth 3/23 regulatory transition that the agency says is aimed at increasing patient access to insulin products. As of 3/23, an online statement says, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act, including applications for insulin and other biological products, will be deemed to be a license for the product under the Public Health Service Act. This change will enable submissions of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products.

“As such,” the notice says, “the transition of insulin products from approved drug applications to deemed biological product licenses will open up these products to potential biosimilar and interchangeable competition. The availability of approved biosimilar and interchangeable insulin products is expected to increase patient access, adding more choices and potentially reducing the costs of insulin products.”

The final rule, Definition of the Term “Biological Product,” amends the FDA regulation that defines a biological product to incorporate changes made by the Biologics and Price Competition and Innovation Act of 2009 and the Further Consolidated Appropriations Act of 2020 and to codify the agency’s interpretation of the statutory term “protein.” Under the rule, protein means “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.”

FDA says its interpretation of the transition provision of the Biologics and Price Competition and Innovation Act is intended to balance innovation and competition and facilitate the development and approval of biosimilar and interchangeable products.

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