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Assist With Monitoring Safety

Overview

Postmarket surveillance is the process of monitoring the safety of a therapy after it has received marketing approval by the U.S. Food and Drug Administration (FDA). Because clinical trials are conducted in small numbers of patients, new issues may arise when a treatment is used by a larger population after approval. Your patient group can provide a bridge between patients, industry, and the FDA to help with postmarket surveillance.

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)