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Congress is considering giving the FDA authority to regulate over-the-counter products through user fees and administrative action, similar to how it regulates prescription drugs. Read More
Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing. Read More
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations. Read More
A bill reauthorizing the FDA’s user fee agreements for the next five years and restructuring fees for biosimilars, including the first year of clinical trials, became law Aug.18 when President Trump signed it. Read More