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 FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

“Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these ...

The FDA proposed new guidelines for approving experimental therapies for rare diseases without large group studies.

In a major shift, the US Food and Drug Administration is relaxing a long-standing drug approval requirement for common diseases.

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for psychedelic drugs, a move that directly clears a path for psilocybin, the active ...

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug ...

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...