On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
1don MSN
Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...
2don MSN
Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
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