The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

Sept 3 (Reuters) - The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including ...

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

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

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...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

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.

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