Drugs

FDA ‘Concerned’ About 505(q) Resource Needs

In a report to Congress, FDA says it “remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing other work of the agency.” The report says Section 505(q) of the Federal Food, Drug, and Cosmetic Act applies to certain petitions asking that the agency take any form of action relating to certain pending drug approval applications.

In this 10^th annual required report to Congress, FDA says that during the FY 2017 reporting period it approved 763 ANDAs, 57 505(b)(2) applications, and three 351(k) applications. No approvals for 351(k) applications or ANDAs were delayed because of 505(q) petitions, it says, and the approval of one 505(b)(2) application was delayed because of one petition.

During FY 2017, FDA received 25 505(q) petitions. The report says the agency reviewed data on the outcomes of 505(q) petitions resolved during FY 2008-FY 2017. “Based on its analysis,” it says, “FDA continues to be concerned that Section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. However, the statute requires FDA to prioritize these petitions about other matters, such as safety petitions, that do raise important public health concerns.”

The agency says that although it has generally met the statutory deadlines for 505(q) petitions, it did so in part by redirecting efforts that otherwise would have been directed to other work, including responding to other citizen petitions.

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