Drugs

FDA Worried About Resources Required to Review Citizen Petitions

FDA says it continues to be concerned about citizen petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. In a just-posted report to Congress on such petitions, FDA complains about its expedited review and responses the statute requires of the petitions because they take away resources that could be used on other petitions, such as safety petitions, that do raise important public health concerns. “Although FDA 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,” the report says. “FDA remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing the other work of the agency.”

The report notes that in FY 2015, FDA approved 492 ANDAs, 45 505(b)(2) applications, and one biosimilar biological product application. “The approval of one ANDA was delayed because of two 505(q) petitions, and the approval of one 505(b)(2) application was delayed because of one 505(q) petition,” it says.” Also during this period, the agency received 15 505(q) 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