Drugs

FDA Launches PreCheck Drug Manufacturing Pilot

FDA has launched its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regulatory engagement and more predictable oversight for new facilities. FDA commissioner Marty Makary says the program is part of a broader effort to reverse decades of offshoring in pharmaceutical manufacturing and improve supply chain resilience. According to the agency, PreCheck is intended to serve as an incentive for companies to build and operationalize manufacturing capacity in the U.S.

The agency plans to select an initial cohort of new pharmaceutical manufacturing facilities and begin PreCheck activities throughout the year. Facilities will be chosen based on alignment with national priorities, including the types of products to be manufactured, the stage of facility development, timelines for supplying the U.S. market, and the use of innovative manufacturing approaches. Additional priority will be given to facilities producing medications considered critical for U.S. patients.

FDA PreCheck will be conducted in two phases. The first, known as the Facility Readiness Phase, will allow selected manufacturers to engage with the agency before a facility becomes operational. This phase includes pre-operational reviews and the use of a facility-specific Drug Master File to enable advance evaluation of manufacturing-related information ahead of a drug application.

The second phase, the Application Submission Phase, will build on the initial engagement through pre-submission meetings and inspections, to resolve issues early and expedite FDA review of manufacturing information included in drug applications.

FDA says additional details on eligibility and selection criteria are available on the agency’s PreCheck program Web page.

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