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German regulators are urging clinical trial sponsors in the UK to designate new, European-based representatives as Brexit’s March 29 deadline draws near. Read More
A bill introduced in the California legislature and endorsed by the state’s attorney general would ban controversial “pay-for-delay” deals between branded and generic drugmakers. Read More
The agency said it will accept nine requests sent before May 30 from applicants who intend to submit NDAs, ANDAs and BLAs that contain proposed CMC conditions that differ from requirements in regulations and guidance. Read More
The agency has sent over 40 warning letters in the past five years to companies that illegally sold products purporting to be Alzheimer’s treatments. Read More
One of the nation’s biggest pharmacy benefit managers owes nearly $16 million in prescription overcharges, according to Ohio’s Attorney General Dave Yost. Read More