Drugs

FDA Draft Guide on ANDA Facility Pre-submissions

FDA has issued a draft guidance on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions. During user fee negotiations, the agency and industry agreed to pre-submission facility correspondence (PFC) to help obtain a shorter GDUFA goal date for priority ANDAs, their amendments, and prior approval supplements. The document encourages PFS submissions two to three months prior to the ANDA, supplement or amendment, saying they will “facilitate the FDA’s assessment of the facilities in the application, including whether an inspection is necessary.”

The guidance also outlines the information that should be submitted in a PFC. “In order to qualify for the shorter review goal date, the information submitted in the PFC must be complete and accurate; there must be no changes with respect to facility information when the applicant submits the associated ANDA, [supplement], or amendment; and the application when submitted must meet the FDA’s criteria for expedited review under the Center for Drug Evaluation and Research’s Manual of Policy and Procedure 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements,” it says. “As defined in the Commitment Letter, a change with respect to facility information is a change to information in the PFC that causes the FDA to re-evaluate its facility assessment.”

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