Drugs

Comments on Expedited IND Pilot

Florence Healthcare says the FDA Expedited IND Pilot Program, part of the government’s Operation TrialBlazer, “takes the right premise seriously: that the United States cannot regulate its way past a site infrastructure problem.” In its response to the agency’s Request for Information, Florence’s comments relate to:

the Qualified Research Institution (QRI) model risks building a credentialing barrier instead of a readiness standard;
addressing post-IND delay requires fixing how site capacity is measured;
digital infrastructure standards must bind sponsors and not just sites;
Institutional Review Board streamlining will underdeliver without addressing local contact review; and
NIH/NCATS-managed infrastructure should not be the default model for the QRI network.

In its response, Amgen says it supports FDA’s goal of accelerating first-in-human clinical trial initiation in the U.S. while preserving critical trial participant safety, scientific rigor, and FDA’s independent regulatory decision-making authority. Its general comments cover:

preserving sponsor accountability and FDA decision-making authority;
clarifying the operational and communication model for QRI participation and rolling review;
establishing objective, fit-for-purpose QRI qualification criteria; and
modernizing and streamlining clinical trial frameworks.

The Cleveland Clinic says academic medical centers can play an important role in improving IND quality, strengthening safety assessment, and providing multidisciplinary clinical and translational expertise. However, it says, pilot success will depend on clearly defined roles, standardized review processes, robust conflict-of-interest safeguards, structured FDA-QRI-sponsor engagement, transparent evaluation metrics, and maintenance of FDA’s ultimate regulatory authority.

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