Adverse Event Final Proposed Rule Comments

CPC’s comments in response to the Proposed Rule for Postmarketing Safety Reporting for Combination Products concerning:

• The proposed rule existing as a “bridge” to a unified regulation.
• The overall impact of the proposed rule on combination products.
• Reporting events to the manufacturer of constituent part or to the FDA.
• The definition of “Constituent Parts” as addressed in the proposed rule.
• Submitting reports on combination products involving multiple applications.
• Reconciling supplemental/overlapping-reporting requirements.
• Reporting to the lead Center.
• Implementation issues.