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The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings. Read More
Dr. Reddy’s Laboratories said it will contest a class-action lawsuit by investors who claim the company made false or misleading statements about its quality system. Read More
As research advances into the biological underpinnings of diseases such as cancer, the FDA is expecting to see more drugs providing more data demonstrating survival benefit earlier in product development, Commissioner Scott Gottlieb told lawmakers at a one-year follow-up hearing on the 21st Century Cures Act. Read More
Each drugmaker’s pharmacovigilance master files and qualified person for pharmacovigilance will have to relocate if they are based in the UK. Read More
Assessors should include information about the drug substances’ general properties and physical characteristics, plus solubility in solvents involved in manufacturing or cleaning processes. Read More
Pharmathen is seeking damages equal to the amount paid to Lachman, the revenues it would have earned from the ANDA and its research and development costs. Read More
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee Wednesday he agrees prescription drug prices are too high, and would welcome congressional action if appointed to the post. Read More