Drugs

Manufacturing/Inspections Discussed Under Next PDUFA

FDA and drug industry representatives are exploring manufacturing and inspection “interests” as part of their Prescription Drug User Fee Act (PDUFA) reauthorization discussions. A recent meeting saw industry explaining its main themes of interest in manufacturing and inspections, such as “enhancing pre-market and post-market communication, increasing understanding of the decision framework around inspections, and streamlining quality-related regulatory submission content,” according to just-posted meeting minutes.

A subsequent meeting had industry presenting their interests for the next user fee program to enhance communications, “particularly around information request (IRs) that are issued during the review process and mid-cycle meeting communications,” according to meeting minutes. “Industry provided insight on the issues with these types of communications and provided examples of how improved communications would allow for more efficient processes for their firms,” it says FDA shared information on current practices and guidelines for IRs and mid-cycle communications, and both parties agreed to continue the discussion on communications at a future meeting.

FDA and industry reps also agreed to discuss industry’s interests in Covid-19 “lessons learned and practices as they relate to ongoing agency workstreams and applicability to PDUFA VII at a future meeting."

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