FDA-Regulated Research Track

2019 AER Conference

A04 - FDA Clinical Holds and 21 CFR 50 Subpart D

Speaker(s)

• 

  David G. Forster, JD, MA, CIP
  

  Chief Compliance Officer, WIRB-Copernicus Group
  
• 

  Kevin A. Prohaska, DO, MPH
  

  Senior Medical Policy Advisor/Bioethics Consultant, Food and Drug Administration
  
• 

  Donna L. Snyder, MD
  

  Senior Pediatric Ethicist and Team Leader, Food and Drug Administration
  

A clinical hold is an order issued by the FDA to the sponsor of an Investigational New Drug (IND) application to delay a proposed clinical investigation or to suspend an ongoing investigation. All or some of the investigations conducted under an IND application may be placed on clinical hold. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and given the investigational drug (patients already in the study are expected to be taken off therapy involving the investigational drug unless treatment continuation is specifically permitted by FDA in the interest of patient safety). The requirements of Subpart D (Additional Safeguards for Children in Clinical Investigations) can be the basis for a clinical hold. During this session, speakers and attendees will:

Learning Objectives:

• Review the FDA’s grounds for imposing a clinical hold and the procedures for issuing a clinical hold
• Discuss situations where deficiencies in 21 CFR 50 Subpart D (Additional Safeguards for Children in Clinical Investigations) may result in a clinical hold
• Share best practices for IRBs to stay informed about the FDA status of a proposed or ongoing study