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FDA Center for Drug Evaluation and Research
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.