"Adverse Event Reporting for OTC Drugs and Dietary Supplements "

1
FDA Notifications and Medwatch Form Requirements

Adverse Event Reporting for OTC Drugs and Dietary
Supplements
2
The Background What You Need to Know
3
Products That Are Covered
4
Definition of a Serious Adverse Event (SAE)

• Section 761(a)(2) of the F,D, C Act

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FDA Notifications - Voluntary SAE Reporting
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FDA Notifications
7
Medwatch Form Requirements (Form 3500A)
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Address for Medwatch Form Hard Copy Submission

• DIETARY SUPPLEMENTS FAX NUMBER FOR ALL AEs
• 1 800 332 - 0178
• FDA Center Food Safety Nutrition
• Office of Food Defense, HFS -11
• 5100 Paint Brach Parkway
• College Park, MD. 20740
• OTC DRUGS
• FDA Center Drug Evaluation Research
• Central Document Room
• 5901-B Ammendale Road
• Beltsville, MD. 20705-1266

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Online Reporting of Medwatch Forms

• Or http//www.fda.gov/Safety/MedWatch/default.htm

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For organizational training on adverse event
reporting and FDA compliance, visit
www.complianceonline.com.

• Thank You