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Zdrowie i gospodarka · 11/12/2014

FDA Releases Draft Guidance on Bioequivalence Recommendations for Budesonide Extended-Release Tablets

The FDA has made available a draft guidance document outlining specific recommendations for bioequivalence studies to support the approval of budesonide extended-release tablets through abbreviated new drug applications (ANDAs)

Source: Federal Register — Food and Drug AdministrationOpen original release →