The Food and Drug Administration is looking to cut down on the time to bring new products to market, two of the agency’s top officials said on June 10.
FDA reviews that usually took a year were completed in weeks during the COVID-19 pandemic, which is “clear demonstration that rapid or instant reviews are possible,” Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a viewpoint published by the Journal of the American Medical Association.
A pilot program will look to speed up the timeline by taking steps such as asking companies to submit much of their paperwork to the FDA before they file their final application, which will enable FDA staff “to examine the manufacturing plans, draft labels, and packaging before a clinical trial is complete,” the officials added….