Researchers publish two journal articles relating to rare disease drug development.
Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.
FDA commissioner Marty Makary says the agency is exploring the use of a new drug approval pathway for rare diseases and incurable conditions.
An FDA Matters blog post analyzes a leaked document purporting to show a 17% decrease in FDA budget authority spending for FY 2026 from the FY 2023 ap...
Two reports highlight U.S. dependence on foreign sources for APIs and finished drugs and call for urgent steps to reduce that dependence.
FDA commissioner Marty Makary announces a new policy directive that limits those employed at regulated industries from serving as official members on ...
Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studies.
A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...