New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings

July 6, 2020

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Development of Anti-Infective Drug Products for the Pediatric Population : Draft Guidance for Industry - Draft Guidance	29 Jun 2020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

*Upcoming Meetings ( = New)**
*	July 14, 2020: Meeting of the Oncologic Drugs Advisory Committee
*	Aug 19-19, 2020: Science Advisory Board to the National Center for Toxicological Research 2020 Meeting

Last updated: 01 July 2020

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