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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
Questions and Answers on FDA's Adverse Event Reporting System (FAERS) U. S. Food and Drug Administration (FDA) (link)
MedWatch: The FDA Safety Information and Adverse Event Reporting Program U. S. Food and Drug Administration (FDA) (link)
Safety Reporting Portal U. S. Food and Drug Administration (FDA) (link)
Reporting Serious Problems to FDA U. S. Food and Drug Administration (FDA) (link)
Medical Product Safety Information U. S. Food and Drug Administration (FDA) (link)
Manufacturer and User Facility Device Experience (MAUDE) U. S. Food and Drug Administration (FDA) (link)
Medical Device Reporting (MDR): How to Report Medical Device Problems U. S. Food and Drug Administration (FDA) (link)
Truthful Prescription Drug Advertising and Promotion U. S. Food and Drug Administration (FDA) (link)
Medication Errors Related to CDER-Regulated Drug Products U. S. Food and Drug Administration (FDA) (link)
Drug Shortages U. S. Food and Drug Administration (FDA) (link)
CDER MAPP on Drug Shortage Management U. S. Food and Drug Administration (FDA) (link)
Requirement and Commitment
Postmarketing Requirements and Commitments: Frequently Asked Questions (FAQ) U. S. Food and Drug Administration (FDA) (link)
Postmarket Requirements and Commitments Searchable Database U. S. Food and Drug Administration (FDA) (link)
FDA's Sentinel Initiative U. S. Food and Drug Administration (FDA) (link)
Sentinel, FDA CDER’s active surveillance program video U. S. Food and Drug Administration (FDA) (link)
Tips for Success
CDER Division of Drug Information U. S. Food and Drug Administration (FDA) (link)
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff U. S. Food and Drug Administration (FDA) (link)
FDA's Sentinel Initiative U. S. Food and Drug Administration (FDA) (link)