Combination products are a key part of the landscape of the Medical Device, Pharmaceutical and Biologics industries today. New approaches to treatment methods and new manufacturing abilities allow more ways to deliver product to patients. The FDA has developed the Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products to help us.
- Provide an overview of the combination products guidance
- Define combination products
- Discuss regulatory paths for combination products
- Examine postmarketing safety reporting requirements for combination products
Collis Laton Floyd