Another interesting session that I was able to attend at the Biocom Drug/Device Summit was about regulatory issues for new in vitro diagnostics and combination products.

Here is a summary of the session’s highlights:

• Combination products can be drug-device, device-biologic, drug-biologic, drug-device-biologic, but not drug-drug.
• Also defined that if a manufacturer co-packages any of the above in a kit then the package is defined as a combination product.
• The FDA has 3 medical products centers:
• CBER (center for biologics evaluation and research)
• CDER (center for drug evaluation and research)
• CDRH (center for devices and radiological health)
• The Office of Combination Products (OCR) assigns products to a center based on primary mode of action. They have developed an assignment algorithm based on the most important therapeutic action, with reasonable certainty.
• OCP has published a recent guidance document, entitled, “Early development considerations for innovative combination products”.
• FDA is working on rulemaking for GMP’s and post market safety reporting for combination products.
• The critical path for combination products includes the following:
• Expertise and expectations
• Identifying regulatory pathway and requirements
• Analytical techniques
• Biocompatibility vs. toxicology
• Bridging device and drug development cycles

Created on Saturday, February 3rd, 2007 at 9:32 am. | Fled under DDL West, Industry Insights. | Comment Feed