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Featured Articles

July 2012

Mark Kramer

Challenges in Combination Product Regulation

by Mark Kramer
President, Regulatory Strategies, Inc.

Combination products raise a variety of regulatory challenges. In addition to the unique technological and scientific challenges these products may raise, when drugs and devices, drugs and biologics or devices and biologics are combined to create a new product, consideration must be given to what regulatory requirements will apply to the combination product as a whole. This article explains the key principles and processes established for the assignment, premarket review, and postmarket regulation of combination products in the United States.

To address the perception that combination products often "fell through the cracks" between the three medical product centers (CBER, CDER and CDRH), in 2002 Congress mandated that FDA establish the Office of Combination Products (OCP). This small office, organizationally located in FDA's Office of the Commissioner, has several key functions to help clarify the regulatory challenges. OCP's key roles are to serve as FDA's "traffic cop," determining which FDA Center will lead the review process for combination as well as non-combination products; to oversee the timeliness of combination product reviews (however, primary responsibility resides with the lead center to which the product is assigned); to serve as a resource for industry and FDA staff on combination product issues; and to develop policy and regulations to clarify combination product issues.

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Deborah Mackin

How to "Sell" Quality

by Deborah Mackin
Performance Strategy Consultant, New Directions Consulting

ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door. Others find that they have to "sell" the rationale for their very existence as quality departments, with leaders eager to cut costs on staffing for quality. Why do we need so much money for labor that doesn't make product/service? Why can't we just build quality into what we do, so quality auditors are unnecessary?

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Regulations Vary Worldwide but Risk Management is Common Denominator

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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Did you know that the FDA has proposed a unique device identification system for medical devices? In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.
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