FDA ADVERSE EVENT REPORTING REQUIREMENTS for OTC DRUGS

Views:
 
     
 

Presentation Description

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

Comments

Presentation Transcript

FDA Notifications and Medwatch Form Requirements :

FDA Notifications and Medwatch Form Requirements Adverse Event Reporting for OTC Drugs and Dietary Supplements

The Background – What You Need to Know:

The Background – What You Need to Know

Products That Are Covered :

Products That Are Covered

Definition of a Serious Adverse Event (SAE):

Definition of a Serious Adverse Event (SAE) Section 761(a)(2) of the F,D, & C Act

FDA Notifications - Voluntary SAE Reporting:

FDA Notifications - Voluntary SAE Reporting

FDA Notifications:

FDA Notifications

Medwatch Form Requirements (Form 3500A):

Medwatch Form Requirements ( Form 3500A)

Address for Medwatch Form Hard Copy Submission:

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

Online Reporting of Medwatch Forms:

Online Reporting of Medwatch Forms Or http://www.fda.gov/Safety/MedWatch/default.htm

Slide10:

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

authorStream Live Help