White Paper: Combination Products – 5 Best Practices to Ensure FDA Compliance

• By: ComplianceOnline
• Date: July 07, 2014

Avoid FDA warning letters for combination product non-compliance by adopting current best practices Confusion still exists among manufacturers as to what regulations cover research and development and marketing as well as FDA approval of combination products. The agency has only recently finalized its Current Good Manufacturing Practices (CGMP) for combination products. This white paper explains the current regulatory environment relating to combination products and five best practices manufacturers should follow in order to achieve FDA compliance and approval.

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