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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
America’s towns and counties could be condensed into a single class to simplify the highly complex litigation against opioid drugmakers, a key plaintiff’s lawyer suggests. Read More
Amgen, Merck, Eli Lilly and the Association of National Advertisers have filed suit against HHS’ rule requiring drug companies to display list prices in TV ads, claiming the requirement will only sow confusion. Read More