Description

In order to successfully market drugs, dietary supplements and cosmetics in the U.S. it’s essential to comply with FDA regulations and communicate with FDA successfully. It’s vital to know how to avoid FDA Warning letters and know how to handle an FDA Warning letter if you receive one.  An FDA Warning Letter can cause you to relabel or reposition your product or even remove it from the market, if not handled properly.  To obtain FDA guidance if there are regulatory issues or if you receive an FDA Warning letter, it’s critical to communicate effectively. This webinar will cover strategies for effective communication with FDA Centers and staff.

Key Points:-

• Small Business & Industry Assistance Meetings
• Proactive and Reactive Strategies for FDA Center communication
• Why companies receive FDA Warning Letters and the consequences of receiving one
• How to avoid and respond to an FDA Warning Letter

What tools and benefits will your session provide to the attendees? 

References to all relevant FDA regulations, Guidance documents, and FDA websites will be provided as well as regulatory insights and know-how tips.

Who will Benefit?

Regulatory Affairs managers, directors & associates, Product managers, Compliance Specialists, Consumer Healthcare companies, Marketing managers and anyone planning to market drugs, dietary supplements or cosmetics in the U.S.A.