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The FDA announced on Tuesday that it will add new information to its patent database, in a move the agency hopes will bring more sunlight into the ANDA approval process. Read More
Nearly three-fifths of European Medicines Agency workers displaced by the ongoing Brexit preparations have made it across the English Channel to temporary headquarters, the agency said. Read More
Acting FDA Commissioner Ned Sharpless says he’d be glad to become the agency’s official boss but even if it’s not him, it’s important to get a permanent commissioner in there soon. Read More
The FDA should stop thinking just about benefits and risks in a product’s lifecycle and adopt a “net-benefits” approach, a contract research organization has urged the agency. Read More
The Drug Enforcement Administration has placed Sage Therapeutics’ recently-approved postpartum depression drug Zulresso (brexanolone) in Schedule IV of its controlled substances list. Read More