Drugs

Generic Post-Warning Letter Meetings Guide

FDA has released a draft guidance entitled “Post-Warning Letter Meetings Under GDUFA” that provides information on implementing the new program that was created during recent generic drug user fee negotiations. Such meetings are described as “a meeting with FDA regarding the facility’s remediation of deficiencies identified in a Warning Letter.”

This guidance describes the process for how an eligible facility may request a meeting, how to prepare and submit a complete meeting request package, and how FDA intends to conduct the meeting. The meetings are intended for facilities to obtain preliminary feedback from the agency on the adequacy and completeness of corrective action and preventive action plans to resolve the inspection-identified GMP deficiencies. “Application-related discussions are not appropriate for post-warning letter meetings,” the guidance says, “even if FDA application assessors attend the meeting. The guidance also does not address requests for re-inspections.”

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