Draft Guidances For 2013 Will Grapple With Biosimilars, Track and Trace, Compounding
FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.
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Additional draft guidances address implementation of the Drug Supply Chain Security Act, multiple endpoints in clinical trials, and public disclosure of FDA-sponsored studies.
FDA says the 13 guidances are out of date and of no use to industry; a number of others covering various topics also will be revised or finalized.
More than a year after hints of forthcoming guidance on missing data, agency looks toward future where sponsors do more to retain patients and follow up on those that leave clinical trials.