Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace 2014 is a conference that covers topics such as:
- What a Combination Product is
- The FDA Office of Combination products
- How to navigate the FDA Combination Product system
- The FDA Combination Product Process
- How to prepare a Request for Designation
- Mode of action and primary mode of action
- GMPs for Combination products
- User Fees for Combination products
- Post-Approval Modifications
Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace 2014 is intended for:
- Research Personnel
- Regulatory Affairs Personnel
- Clinical Personnel
- Quality Personnel
- Personnel who require an understanding of the FDA Combination Product Process
- Manufacturing Personnel