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 ...

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.

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 ...

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 ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

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 ...