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Drugmakers seeking marketing authorization in the EU may request a meeting with the European Medicines Agency to discuss questions posed by the agency’s advisory committees, updated guidance says.
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A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
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