The FDA Fast Track process features regular interactions with the FDA, including the potential for early and rolling review ...

“The FDA recognizes that there’s a problem, so they have begun to formulate a plan to put a system in place, and they made ...

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

The drugmaker will also get the FDA's priority review voucher, which allows a drug developer to expedite the review process ...

A researcher has filed a lawsuit against the Drug Enforcement Administration, accusing the agency of multiple legal ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...

Up until now, drivers who have a failed drug or alcohol test reported to the Clearinghouse ... of “prohibited” status by ...

The Food and Drug Administration (FDA) is proposing to officially remove a popular ingredient in many cold and allergy ...

Zeid Barakat began the discussion by highlighting how well-executed CMC can be a key strategic asset, enabling drug supply to ...

The FDA estimates the accelerated process gets drugs to patients with cancer about 3 years faster than if initial approvals ...

In the pursuit of youthful aging and vitality, many individuals find themselves exploring various supplements and health ...