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3. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff


5. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters


6. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment


7. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products


8. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment


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