| Special Interest Guidances/Information | Date Posted |
| Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders – Draft Guidance | 31 August 2020 |
| CVM GFI #191 Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs – Final Guidance | 27 August 2020 |
| Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry – Final Guidance | 27 August 2020 |
| Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for Industry – Final Guidance | 26 August 2020 |
| Evaluating Cancer Drugs in Patients with Central Nervous System Metastases: Draft Guidance for Industry – Draft Guidance | 25 August 2020 |
| Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers: Guidance for Industry – Final Guidance | 19 August 2020 |
| Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) : Guidance for Industry – Final Guidance | 18 August 2020 |
| Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for Industry – Draft Guidance | 17 August 2020 |
| Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff – Final Guidance | 14 August 2020 |
| Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff – Final Guidance | 14 August 2020 |
| Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff – Final Guidance | 14 August 2020 |
| Male Breast Cancer: Developing Drugs for Treatment: Guidance for Industry – Final Guidance | 12 August 2020 |
| Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic ActMarketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act – Final Guidance | 10 August 2020 |
| Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Draft Guidance for Industry – Draft Guidance | 07 August 2020 |
| Bioresearch monitoring technical conformance guide – Final Guidance | 05 August 2020 |
| Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry – Final Guidance | 05 August 2020 |
| Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants – Final Guidance | 04 August 2020 |
| CPG Sec. 280.100 – Stability Requirements – Licensed In Vitro Diagnostic Products – Final Guidance | 31 Jul 2020 |
| CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents – Final Guidance | 31 Jul 2020 |
