FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This ...

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what ...

ORLANDO, Fla. — The FDA is initiating a program to improve retailer compliance in order to fight youth vaping, focusing on vape shops, convenience stores, and gas stations nationwide. The initiative ...

A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies ...

Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally. In October, ...

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 ...

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

First step in Transforming Product Quality for a Safer World At Innova-Q our goal is to transform product quality for a safer world. The launch of the In-Q Center is the first of many innovations that ...

TORRANCE, Calif., July 12, 2024 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCPK: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today ...