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Start Over You searched for: Subjects Investigational New Drug Application Remove constraint Subjects: Investigational New Drug Application Subjects United States. Department of Health and Human Services. Remove constraint Subjects: United States. Department of Health and Human Services. Publication Year 2017 to 2019 Remove constraint Publication Year: <span class="from" data-blrl-begin="2017">2017</span> to <span class="to" data-blrl-end="2019">2019</span>

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12. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

13. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

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

15. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

16. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

18. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

19. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

20. Smallpox (variola virus) infection: developing drugs for treatment or prevention