Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...

Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...

Officials with the FDA have announced virtual public meetings to discuss the Animal Drug User Fee Act (ADUFA) and Animal ...

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

In a landmark week for medical innovation, the FDA approved or cleared multiple breakthrough technologies, from the first gene therapy for genetic hearing loss to a wireless brain implant trial for ...

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...

The US FDA has begun accepting applications for its pilot PreCheck program, which is designed to ease the process for pharma companies to build new manufacturing facilities in the US. The program is ...

The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s ...