This 2 hours webinar will provide a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.
A must attend webinar for those who have Combination Products or are anticipating that they will be developing Combination Products. This webinar explains the entire FDA Combination Product Process and how to navigate the FDA Combination Product system. This webinar provides a comprehensive understanding of the FDA Combination Product Process including the FDA Office of Combination Products, mode of action, primary mode of action and how to prepare a Request for Designation submission. If your concern is to get your Combination Product on the USA marketplace this webinar is a must attend for you.
Areas to be Covered:
FDA Office of Combination Products
FDA Combination Product Process
How to navigate the FDA Combination Product system
Mode of Action and Primary mode of action
How to prepare a request for designation submission
How to interact with the FDA Office of Combination products
Who will Benefit:
Regulatory Affairs Personnel
Clinical Research Associates
Personnel who require a general understanding of the USA Combination Product Process.