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.
Hahn said that the agency hasn’t had time to check yet whether the APIs from India are used in the 20 drugs the agency identified as being at-risk for shortages. 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
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diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says.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
Clinical trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says. Read More
The FDA detailed how and when drug sponsors should evaluate the nonclinical toxicity of drug metabolites, in a final guidance released Friday. Read More
India’s pharmaceutical agency reported last week that the country has enough active pharmaceutical ingredients to fuel its manufacturing operations for three months. But the rest of the world may not be as fortunate, with some APIs from the two largest global suppliers — China and India — now interrupted. Read More