The agency is proposing a requirement that companies submit data when self-affirming an additive is safe for consumption.

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...

The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare ...

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access 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 agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

Scientists reached a major milestone in animal-to-human transplant research as the FDA approved the first human clinical ...

Microbot Medical describes its product as "intended for use in the remote delivery and manipulation of guidewires and ...

FDA-approved clinical trial will allow Mass General Hospital and eGenesis to involve transplant patients nationwide.