MedWatch

Definition

MedWatch is the FDA's reporting system for monitoring adverse events and product problems associated with medical products. It aims to ensure patient safety and improve the quality of healthcare.

5 Must Know Facts For Your Next Test

1. MedWatch allows healthcare professionals and consumers to report adverse events and product problems voluntarily.
2. The program collects data on drugs, biologics, medical devices, dietary supplements, and cosmetics.
3. Reports can be submitted online, by mail, or by fax using Form FDA 3500.
4. MedWatch plays a crucial role in post-marketing surveillance of medical products.
5. Information gathered through MedWatch can lead to safety alerts, drug recalls, or changes in product labeling.

Review Questions

• What is the primary purpose of the MedWatch program?
• Which types of products can be reported through MedWatch?
• How can reports be submitted to MedWatch?

Related terms

Adverse Event: An undesired harmful effect resulting from a medication or other intervention.

Post-Marketing Surveillance: The practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market.

Drug Recall: The action taken to remove a defective or potentially harmful drug from the market.