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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diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says.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
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trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says.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