Guidance Documents Home / Resources / Guidance Documents Enter Keyword Topic/Sub-Topic All ADHD Alzheimer’s Disease ANDA vs 505(b)(2) Anitcancer: Non-clinical Studies Bioanalytical Biomarkers Biosimilars Biowaiver Classification Bispecific Antibody Chronic Hepatitis C Virus Combination Products Demonstrating Interchangeabilty Doxorubicin Hydrochloride Drug Adnimistration Drug Development Guidance Drug Development Guidance Drug Interaction Studies Drug Metabolites Drugs and Biologics Dystrophinopathies Elemental Impurities Gene Therapy Generics HBV HIV-1 Immunogenicity Testing Labeling Liposome Drug Products Method Validation Nanomaterials NASH Nicotine: Non-clinical Studies Novel Coronavirus/COVID-19 Oligonucleotides Oncology Paediatric Medicines: Non-clinical Studies Product Quality Assessments Qualification Framework Radiopharmaceutical Diagnostic Radiopharmaceutical Oncology Rare Disease Safety Testing Safety Testing Serious Conditions Study Design Study Guidance Therapeutic Protein Products Toxicokinetics Toxicology Waiver of In Vivo studies HIV-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Status: Final Organization: FDA Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Status: Draft Organization: FDA Rare Diseases: Common Issues in Drug Development Status: Final Organization: FDA Rare Diseases: Natural History Studies for Drug Development Status: Final Organization: FDA Guideline on drug interaction for drug development and appropriate provision of information Status: Draft Organization: PMDA Determining Whether to Submit an ANDA or a 505(b)(2) Application Status: Final Organization: FDA Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection Status: Final Organization: FDA ICH guideline M10 on Bioanalytical Method Validation Status: Draft Organization: EMA Principles of Premarket Pathways for Combination Products Status: Draft Organization: FDA Biomarker Qualification: Evidentiary Framework Status: Draft Organization: FDA ICH guideline M9 on bipharmaceutics classification system based biowaivers Status: Draft Organization: EMA Duchenne Muscular Dystrophy and Related Dystrophinopathies: Drug Development Status: Final Organization: FDA Page1 Page2 Page3 Page4 Page5
HIV-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Status: Final Organization: FDA
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Status: Draft Organization: FDA
Guideline on drug interaction for drug development and appropriate provision of information Status: Draft Organization: PMDA
Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection Status: Final Organization: FDA
ICH guideline M9 on bipharmaceutics classification system based biowaivers Status: Draft Organization: EMA
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Drug Development Status: Final Organization: FDA