Drugs

FDA Launches Pilot to Speed Up Meeting Minutes

FDA has launched a new pilot program aimed at reducing delays and confusion that often follow formal meetings between the agency and drug developers. Announced 11/19 by FDA commissioner Marty Makary, the initiative creates a streamlined process for companies to get rapid clarification on specific points in their official meeting minutes.

Under the new “Meeting Minute Clarification Opportunity,” sponsors can email a single-discipline question to FDA staff and expect a response within three business days — a dramatic acceleration compared with traditional follow-up timelines.

“In this industry, time is a precious commodity,” Makary was quoted in an FDA release as saying. “Developers have told me that a quick touchpoint with the FDA team could spare them months of guesswork. Our goal is to give sponsors prompt, clear feedback so they can focus on what they do best: delivering more cures and innovative treatments.”

The pilot, which quietly began last month, has already been used by several companies seeking quick clarifications on FDA guidance after receiving meeting minutes. The agency said the system has proven useful in resolving straightforward questions that otherwise might require lengthy correspondence or additional meetings.

The initiative is being run by CDER’s Office of New Drugs and is part of a broader push to modernize the drug development process by improving communication and predictability for sponsors. FDA said it plans to expand these faster communication practices across other centers if the pilot continues to show value.

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