The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Phillips Industries’ new Cincinnati-area distribution center is now shipping aftermarket ...
In clinical trials, the drug was shown to almost double the median survival time for patients with pancreatic cancer.
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 ...
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 ...
Sanofi has asked the FDA to pull its type 1 diabetes drug out of Commissioner Marty Makary’s new speedy drug review program.
In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
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 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 ...