The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies ...

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 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 cases supported by ...

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...

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 ...