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Start Over You searched for: Subjects United States. Food and Drug Administration. Remove constraint Subjects: United States. Food and Drug Administration. Subjects Investigational New Drug Application Remove constraint Subjects: Investigational New Drug Application Genre Guideline Remove constraint Genre: Guideline Dates by Range 2000 and later Remove constraint Dates by Range: 2000 and later
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13. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

nlm:nlmuid-101704838-pdf

16. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

nlm:nlmuid-101720038-pdf