Guidance documents for NDA (US FDA)

  • Bioavalibility and Bioequivalence Studies for Orally Administered Drug ProductsGeneral Considerations
  • Changes to an Approved NDA or ANDA
  • Container Closure Systems for Packaging Human Drugs and Biologics
  • Format and Content of the Microbiology Section of an Application
  • Format and Content of the Clinical and Statistical Sections of an Application
  • Format and Content of the Summary for New Drug and Antibiotic Applications
  • Formatting, Assembling and Submitting New Drug and Antibiotic Applications
  • Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
  • Submitting Samples and Analytical Data for Methods Validation
  • Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products
  • NDAs: Impurities in Drug Substances
  • Format and Content of the Human Pharmacokinetis and Bioavaliability Section of an Application
  • Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application
  • Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
  • Drug Master Files
  • Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders
  • Qualifying for Pediatric Exclusivity
  • PET Drug Applications-Content

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