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Assist With Monitoring Safety

Purpose of Surveillance

You can ensure the FDA has the information it needs to protect your patient community by explaining the importance of postmarket surveillance to both your patient community and your network of health care providers. Postmarket surveillance can:

  • Detect unexpected adverse effects or an increase in severity including:
    • Adverse reactions
    • Poisonings
    • Medical complications
  • Monitor adherence to the terms and conditions of approval.
  • Track manufacturing consistency and control.
  • Lead to labeling updates. 
  • Trigger approval re-evaluation.

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)