Drugs

Final Year of CMC Development Pilot Opens Oct. 1

FDA says it will begin accepting requests on 10/1 from drug and biologics sponsors seeking to participate in the fifth and final year of its Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program.

The CDRP program, established under the PDUFA VII commitment letter for fiscal years 2023 through 2027, is intended to help sponsors of products with accelerated clinical development timelines ensure that their CMC programs are sufficiently advanced to support a marketing application.

Sponsors selected for the pilot receive additional opportunities to interact with FDA on product-specific manufacturing issues during development. Those include two additional CMC-focused Type B meetings and a limited number of other CMC discussions tied to development milestones and manufacturing readiness. FDA said the increased communication is intended to establish a mutual understanding between sponsors and review staff about the work needed to complete CMC activities and achieve readiness for an application.

FDA has published eligibility and selection criteria, along with instructions for requesting participation.

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