Drugs

FDA Announces Pilots on CMC Changes, Hybrid Inspections

FDA has announced two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the agency is a member, is spearheading and seeking industry participants — one on collaborative assessments of chemistry, manufacturing and control (CMC) related post-approval changes and the other on hybrid inspections. FDA says the main objectives of the two pilots include:

Development of an initial common framework for collaborative assessment and hybrid inspections;
Identification of best practices and standards in the quality assessment of CMC-related post-approval changes and collaborative hybrid inspections to inform relevant quality assessments;
Delivery of a single list of questions to the sponsor or manufacturer that identifies any misalignments, differences, and potential areas for alignment or harmonization across participating regulators’ regions;
Sharing of the sponsor’s or manufacturer’s responses with the participating quality assessors/inspectors who will work toward a common approach to assessment and decision making;
Identification of the conditions (products/cases) on which cross-regional collaboration efforts in the collaborative assessment and hybrid inspection pilots should focus and the development of recommendations for a future cross-regional pathway(s) to be pursued by ICMRA.

Both pilots are expected to last for one year, and a summary report will be published after the end of the pilot programs in 2023. Further information on the two collaborative pilots, key considerations and the application procedure is available on the ICMRA website.

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