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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
The Supreme Court Tuesday refused to hear Maryland’s appeal to revive a state law aimed at preventing drug companies from “price-gouging” consumers. Read More
CBER on Wednesday issued its list of guidance it expects to release in 2019, including final versions of several gene therapy drafts issued in 2018. Read More
The Federal Trade Commission has reached a global settlement resolving three antitrust lawsuits against Teva Pharmaceuticals subsidiaries. Once approved by the courts, the settlement will bar the drugmaker from reverse-payment patent deals that restrict patient access to less expensive generics. Read More
The agency’s approval followed an Oct. 12 meeting of the Anesthetic and Analgesic Product Advisory Committee, which voted 10 to 3 that the drug’s benefits outweighed its risks. Read More
Several comments expressed concern over the agency’s suggestion that it might be open to using data from observational studies that “replicate” randomized trial results and worried that the word is too vague. Read More