Dietary Supplements and OTC Drugs - Adverse Event Reporting
Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs.
Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to answer.
Why Should You Attend:
There are often questions about what FDA considers to be an adverse event and about Adverse event reporting requirements for Dietary Supplements and OTC drugs. This Webinar will help to answer those questions and will help assure manufacturers and importers that they comply with the law.
Areas Covered in the Session:
Who Will Benefit:
- Adverse event reporting and recordkeeping requirements of the Dietary Supplement &Nonprescription Drug Consumer Protection Act
- Questions & Answers regarding the Labeling of Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Anyone who wants to market OTC drugs in the U.S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/webinar:
- Regulatory Professionals
- Drug Marketers
- Manufacturers and Distributors
- Students of FDA Regulations