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 Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts Status: Final Organization: FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Status: Final Organization: FDA Human Gene Therapy for Hemophilia Status: Final Organization: FDA Human Gene Therapy for Rare Diseases Status: Final Organization: FDA Human Gene Therapy for Retinal Disorders Status: Final Organization: FDA Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Status: Draft Organization: FDA Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations Status: Draft Organization: FDA In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Status: Final Organization: FDA Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Status: Final Organization: FDA Biosimilars: Considerations in Demonstrating Interchangeability With a Reference Product Status: Final Organization: FDA Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Status: Draft Organization: FDA Bispecific Antibody Development Programs Status: Draft Organization: FDA Page1 Page2 Page3 Page4 Page5
Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts Status: Final Organization: FDA
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Status: Final Organization: FDA
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Status: Draft Organization: FDA
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations Status: Draft Organization: FDA
In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Status: Final Organization: FDA
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Status: Final Organization: FDA
Biosimilars: Considerations in Demonstrating Interchangeability With a Reference Product Status: Final Organization: FDA
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Status: Draft Organization: FDA