We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Leaders of the House Energy and Commerce Committee asked FDA Commissioner Stephen Hahn how the agency intends to weigh priorities for the notification of shortages while protecting commercial information as the coronavirus continues to spread. Read More
Colorado — one of five states with drug importation plans in the works — submitted its plan for importing prescription drugs from Canada to HHS for approval yesterday. Read More
FDA Commissioner Stephen Hahn announced yesterday that the agency has suspended most foreign inspections through April in response to the COVID-19 outbreak. Read More
The FDA issued a warning letter to an active pharmaceutical ingredient and over-the-counter drug manufacturer in the Chinese port city of Guangzhou for releasing products without performing microbial tests. Read More
The FDA issued a 14-observation Form 483 to Irvine, California drugmaker Stason Pharmaceuticals for inadequate testing and other quality failures. Read More
The FDA hit JHS Svendgaard Hygiene Products with a warning letter for serious GMP failures at its drug manufacturing facility in Himachal Pradesh, India. Read More
Sponsors of drugs to improve glycemic control in patients with Type 2 diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says. Read More
In a blow to Genentech’s blockbuster cancer drug Herceptin, a federal appeals court refused to temporarily suspend sales of Amgen’s biosimilar while a lower court considers a patent infringement challenge. Read More