| Special Interest Guidances/Information | Date Posted |
| Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance | 31 Jul 2020 |
| Multiple Function Device Products: Policy and Considerations – Final Guidance | 29 Jul 2020 |
| Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval – Final Guidance (Revision 1) | 29 Jul 2020 |
| Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format – Draft Guidance (Revision 1) | 29 Jul 2020 |
| Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products – Final Guidance | 29 Jul 2020 |
| Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products – Draft Guidance | 28 Jul 2020 |
| Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use – Final Guidance | 21 Jul 2020 |
| Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research – Draft Guidance | 21 Jul 2020 |
| Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency – Final Guidance | 20 Jul 2020 |
| Clinical Investigations for Prostate Tissue Ablation Devices – Final Guidance | 15 Jul 2020 |
| Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act – Final Guidance | 15 Jul 2020 |
| Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections – Final Guidance | 10 Jul 2020 |
| Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies – Final Guidance | 10 Jul 2020 |
| Cancer Clinical Trial Eligibility Criteria: Brain Metastases – Final Guidance | 10 Jul 2020 |
| Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients – Final Guidance | 10 Jul 2020 |
| Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking – Final Guidance | 01 Jul 2020 |
