FDA U-turns on rare disease treatment: what it means for patients

A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.
JD Supra

New FDA approval process promotes development of rare disease gene 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 ...
RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...
Managed Healthcare Executive

FDA approves new sunscreen ingredient, first time in 20 years

The FDA has approved a new sunscreen ingredient called bemotrizinol for use in the United States, marking the first time in ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

The FDA finally approved a new sunscreen ingredient. It only took over 25 years.

The U.S. has led the world in several innovations in recent decades: the iPhone, Facebook, and artificial intelligence. But ...
WSAV-TV on MSN

US catches up to rest of world with first new FDA-approved sunscreen in decades

The Food and Drug Administration (FDA) this week approved the first new sunscreen filter in more than two decades, sparking ...