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.

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 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 ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

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

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 ...