Drugs

GDUFA Post-Warning Letter Meeting Guidance

FDA has published a guidance, Post-Warning Letter Meetings Under GDUFA, with information on the implementation of the post-Warning Letter meeting process for certain facilities as covered in the GDUFA 3 commitment letter. The document says a post-Warning Letter meeting is a meeting with FDA about the facility’s remediation of deficiencies identified in a Warning Letter.

The guidance describes the process in the commitment letter for how an eligible facility may request a post-Warning Letter meeting with FDA about the facility’s ongoing remediation efforts to address CGMP deficiencies described in a Warning Letter, how to prepare and submit a complete meeting request package, and how FDA intends to conduct the meeting.

The guidance includes an Introduction, Background, GDUFA performance goals, Post-Warning Letter Meetings, Eligibility Criteria, Meeting Requests for Post-Warning Letter Meetings, Assessing Meeting Requests, Rescheduling and Canceling Post-Warning Letter Meetings, and Procedures for Conduct of Meetings.

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