We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has cited Actavis Totowa for deficiencies with its quality control unit, including a failure to investigate out-of-specification test results and to record all data.
The FDA issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children.
Former FDA Commissioner Lester Crawford will have to pay $90,000 in penalties and serve three years of probation for federal fraud charges levied against him for failing to disclose financial conflicts of interest and making false statements, his attorney said.
The FDA warned Abraxis Bioscience for distributing pharmaceuticals that could have been contaminated during manufacture and for marketing drugs without approved new drug applications.
Bell-More Laboratories failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.
FDA staff say the Critical Path Initiative (CPI) is in trouble, with insufficient funding leaving employees working on the program during their off hours.
The U.S. Court of Appeals for the District of Columbia heard arguments last week in a landmark case to decide if terminally ill patients have a constitutional right to use drugs that have not been fully approved by the FDA.
The FDA has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
The FDA is reviewing the safety and efficacy of cough and cold medications for children to decide whether the methods used to determine dosages were sufficient, the agency announced.