In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...

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 ...

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 ...

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 ...

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not operate this way; it is built to evolve.

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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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 ...

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...

FDA commissioner Marty Makary said it would be “magical” for consumers to see prescription drugs on pharmacy shelves instead ...