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Takeda and Lundbeck have requested that the FDA require all applicants for generics of their antidepressant, Trintellix (vortioxetine), to include information on the med’s association with sexual dysfunction. Read More
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