Drugs

Workshop on NDA/BLA Meeting Management Practices

FDA is announcing a 7/22 public workshop on “Best Practices for Meeting Management Under PDUFA VII.” The agency says that with increasing interaction meetings available to industry, “optimizing meeting management practices has become more important to facilitate the conduct of efficient and effective drug development programs.”

Under the user fee agreement between FDA and industry, a third-party assessment has been conducted that evaluated the current state of meeting management. Data from the assessment will be discussed during the public workshop and stakeholders will “share perspectives on the relevant data as it relates to meeting management good practices,” a workshop notice says. “Topics will include, but not be limited to, issues related to submission of meeting requests, efficient time management, coordinating meeting agenda, development and submission of meeting background packages and lessons learned from the Coronavirus Disease 2019 pandemic including virtual meeting platforms,” it says.

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