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Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
The FDA’s Drug Safety Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committees will meet jointly in early July to discuss whether postmarket studies of reformulated OxyContin extended-release tablets show reduced misuse and abuse of the blockbuster pain reliever. Read More
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
The FDA’s Drug Safety Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committees will meet jointly in early July to discuss whether postmarket studies of reformulated OxyContin extended-release tablets show reduced misuse and abuse of the blockbuster pain reliever. Read More
New FDA-approved labeling for the antibiotic meropenem adds another pediatric indication to the drug’s portfolio, this time for treating complicated intra-abdominal infections in children younger than three months old. Read More