Special Interest Guidances/Information |
Date Posted |
Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry - Final Guidance |
30 Jun 2020 |
Review and Update of Device Establishment Inspection Processes and Standards: Guidance for Industry - Final Guidance |
29 Jun 2020 |
Development of Anti-Infective Drug Products for the Pediatric Population : Draft Guidance for Industry - Draft Guidance |
29 Jun 2020 |
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers: Guidance for Industry and Food and Drug Administration Staff - Final Guidance |
22 Jun 2020 |
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry - Final Guidance |
19 Jun 2020 |
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff - Final Guidance |
19 Jun 2020 |
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry - Final Guidance |
16 Jun 2020 |
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency: Guidance for Industry - Final Guidance |
08 Jun 2020 |
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff - Final Guidance |
05 Jun 2020 |
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry - Final Guidance |
04 Jun 2020 |
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators: Guidance for IRBs and Clinical Investigators - Final Guidance |
02 Jun 2020 |
CVM GFI #240 Proprietary Names for New Animal Drugs - Final Guidance |
01 Jun 2020 |