LOS ANGELES (KABC) -- The Food and Drug Administration's approval process is one of the most stringent in the world, but now some experts are questioning newer drugs that go through a quicker review.
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An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...
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
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
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 ...
The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...
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