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 COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Status: Final Organization: FDA COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products Status: Final Organization: FDA FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Status: Final Organization: FDA Policy for Coronavirus Disease-2019 Tests During The Public Health Emergency (Revised) Status: Final Organization: FDA 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
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Status: Final Organization: FDA
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products Status: Final Organization: FDA
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Status: Final Organization: FDA
Policy for Coronavirus Disease-2019 Tests During The Public Health Emergency (Revised) Status: Final Organization: FDA
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