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Adverse Event Reporting for OTC Drugs and Dietary Supplements

ComplianceOnline webinar on regulatory requirements for adverse event reporting for dietary supplements and OTC products

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Adverse Event Reporting for OTC Drugs and Dietary Supplements

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Presentation Transcript

  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

  5. FDA Notifications - Voluntary SAE Reporting

  6. FDA Notifications

  7. Medwatch Form Requirements (Form 3500A)

  8. 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

  9. Online Reporting of Medwatch Forms Orhttp://www.fda.gov/Safety/MedWatch/default.htm

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

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