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.
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diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says.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
The FDA issued a warning letter to an over-the-counter drug manufacturer in New Jersey for failing to maintain its facility in a good state of repair and other serious GMP violations. 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trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says.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