The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, ...
Federal regulators have unveiled a pilot program for clinical trials that they say will reduce the time it takes to test drugs. The Food and Drug Administration program will feature real-time clinical ...
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
During a public hearing on Thursday, the US Food and Drug Administration (FDA) received several suggestions from industry stakeholders on how to improve its Commissioner’s National Priority Voucher ...
New York lawmakers won't pass a 340B drug program protection bill this session, disappointing hospitals and health centers ...
The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...
FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...
WASHINGTON — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Trump’s administration is causing alarm across the agency, stoking ...
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