Webinar on FDA Approval Process for Combination Products

Description :

This 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.

Areas Covered in the Session :

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

Q&A Session

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Legal Personnel

Auditors

Clinical Research Associates

Personnel who require a general understanding of the USA Combination Product Process