Assist With Monitoring Safety

Tips for Success

  • Talk to the Sponsor about including your patient registry or natural history study as part of its postmarket commitment or requirement if included in the NDA.
  • Keep your disease community aware of any postmarket surveillance and the importance of participating in any Phase IV Clinical Trials, patient registry, or natural history studies that are part of the surveillance. 
  • Reach out to other group leaders who may have a therapy currently in postmarket surveillance or recently completed required or committed phase of postmarket surveillance.
  • Share the contact information of the FDA Division of Drug Information with your disease community.
    • Staffed by pharmacists who can assist in answering questions about specific drugs and biologics as well as assist in reporting adverse events.
    • Email: druginfo@fda.hhs.gov 
    • Telephone: 1-855-543-3784 or +1-301-796-3400
  • Stay current with FDA programs and resources. For example:
    • Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff (2019) is a draft published by the FDA. This document is written in technical language, but may be of interest to you or those in your patient community who prefer to understand as much as possible about a topic. 
      • Includes sections for different types of therapies and specific patient populations.
      • Discusses safety signal identification, evaluation and documentation.
    • FDA’s Sentinel Initiative is a growing FDA initiative which has transformed the way researchers monitor the safety of FDA-regulated therapies, including drugs, biologics, and medical devices.

Resources

FDA Surveillance Programs
Requirement and Commitment
Tips for Success