Drugs

FDA Clarifies Field Action Reports Guidance

Attorney Jennifer Davidson (Kleinfeld, Kaplan & Becker) says an FDA 7/18 draft question-and-answer guidance on field alert report (FAR) submissions clarifies the circumstances under which a FAR should be submitted. FDA regulations says a FAR should be submitted to the agency within three working days of receipt of any of these types of information: situations in which a drug product may be mistaken for another product; bacterial contamination; any significant chemical, physical, or other change or deteriorations in the distributed drug product; and any failure of a distributed batch of the drug product to meet the specifications established in its application.

The clarification of report submission criteria covers each of the categories and notes that a FAR must be submitted even if the sponsor believes the root cause of the quality defect has been identified and corrected, Davidson says. Also, a recall does not obviate the requirement to submit a FAR.

The guidance says that all drug products marketed under an NDA or ANDA are subject to FAR requirements, including those distributed only outside the U.S.

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