Drugs

FDA Guide on 505(q) Citizen Petitions

FDA has finalized a guidance on “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document provides information on FDA’s current thinking on interpreting Section 505(q) of the Food, Drug, and Cosmetic Act, which governs certain citizen petitions and petitions for a stay of action by requesting that the agency take any form of action related to a pending application described in section 505(b)(2) or 505(j) or a pending application described in Section 351(k) of the Public Health Service Act. It also describes FDA’s interpretation of Section 505(q) about how the agency determines if (1) the provisions of section 505(q) addressing the treatment of citizen petitions and petitions for stay of action apply to a particular petition and (2) a petition would delay approval of a pending ANDA, 505(b)(2) application, or 351(k) application.

An FDA news release says the guidance is intended to address “gaming” by would-be competitors by filing such petitions. “It seeks to lessen the impact that FDA review of certain citizen petitions may have on any pending approval actions,” it says. “The approach would help the FDA allocate resources efficiently when addressing petitions that are most likely to present an obstacle to the availability of generic drugs. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the guidance states that the FDA would expect to respond to that petition within 150 days... The FDA will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval, as citizens petitions can raise relevant concerns.”

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