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Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More
The FDA’s Office of Prescription Drug Promotion warned a Valeant Pharmaceuticals subsidiary for failing to include risk information in promotional material for a cough suppressant. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. Read More
The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More