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White Paper: 4 Things You Need to Know About Combination Drug Compliance

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Combination products are a fascinating area of the pharmaceutical industry and present great future promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It has grown solidly at a rate of 7.9% CAGR since 2013, and is projected to continue at that rate through 2019.1

Some of the key factors driving this growth include: higher levels of patient compliance, demand for minimally invasive surgeries, opportunities for precise pain relief, quicker healing and governments and non-governmental organizations (NGO) embracing combination drugs for their ease of administration.

However, combination drugs present unique challenges addressed in this paper:

  • What is 21 CFR Part 4?
  • Understanding the Role of the FDA’s Office of Combination Products
  • Bringing Legacy Combination Products into Compliance with 21 CFR Part 4
  • Streamlined Approach for Review and Approval of Some Combination Products