The IND pilot is part of the HHS's ongoing mission to onshore clinical trials.

First teased in June and formally announced Tuesday as part of “Operation Trialblazer,” the program will partner drugmakers with research institutions to more quickly bring drugs into human testing.

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of ...

This year, an unspecified number of drug developers will be eligible to take part in a pilot of the new US Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) program, ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...

On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by ...

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 ...

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Marty Makary, M.D., said in a statement. “The FDA PreCheck initiative is one of many ...

THE WEIGHT IS OVER — Danish drugmaker Novo Nordisk won FDA approval Thursday for a higher dose of its weight-loss drug Wegovy — a decision FDA Commissioner Marty Makary touted on social media because ...

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 ...

Federal regulators have unveiled a pilot program for clinical trials that they say will reduce the time it takes to test drugs. The Food and Drug Administration program will feature real-time clinical ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...