By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS

 

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Development of Anti-Infective Drug Products for the Pediatric Population : Draft Guidance for Industry – Draft Guidance 29 Jun 2020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