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November 2012

Marla Scarola

FDA User Fees: What Have They Done for You Lately?

by Marla Scarola
M.S., RAC, Senior Consultant, The Weinberg Group Inc.

The U.S. Food and Drug Administration (FDA) user fees have been a fact of life for regulated industry for nearly two decades. Over the past 20 years, the Prescription Drug User Fee Act (PDUFA) has allowed FDA to speed up review times for new drug applications (NDAs) and biologic license applications (BLAs), ultimately decreasing the amount of time it takes drugs and biologics to reach the market.

PDUFA provides FDA with the authority to collect fees from pharmaceutical and biotechnology companies for the review of certain human drug and biological products. These fees have slowly increased with each iteration of the bill, allowing FDA additional resources to add new goals and objectives to the act.

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Peter Knauer

Single Sourcing of Critical Components: Strategies for Optimization

by Peter Knauer
Partner Consultant, MasterControl Quality and Compliance Advisory Services

The increase in virtualized or under-resourced biomedical companies has resulted in a dramatic shift in outsourcing components and supplies. Larger companies are also joining this outsourcing trend. Even more profound is the development of reliance on single sourced suppliers, particularly for critical components. While this can be an effective way to improve cost of goods and efficiencies, there are some significant risks associated with this practice. This paper examines these risks and addresses strategies to dispatching or mitigation these concerns.

FDA makes yearly data available on importation of biomedical raw materials, devices and components, as shown below (source: FDA.org). Focusing on medical devices alone, imports have increased four fold in the eight years shown below. In fact, FDA cites this rapid increase as reason for replacing its current Oasis import inspection program with PREDICT, which is being piloted on the West Coast in 2012. PREDICT implements a risk-based rating system for each shipment, which scrutinizes safety, inspection history, import frequency and complexity to determine disposition of that product. The rapid increase manifested below is also indicative of biomedical companies' increased reliance on outsourcing as a whole. Technical transfer complexities, resource constraints, regulation issues, cost of goods (COGs) improvements, travel budgets, hiring difficulty and mergers/acquisitions all play a role. The bottom line is that this trend will continue and accelerate.

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Cindy Fazzi

Clinical Research: Common Challenges in Sponsor-CRO Relationship

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Outsourcing thrives in good times and bad. Life science companies rely on contract research organizations to complement in-house work in times of growth and expansion, but they also rely on CROs to reduce costs in times of financial downturn.

This is especially true with pharmaceutical companies that sponsor clinical trials. Over the past decade, the annual growth for drug sponsor spending for CRO services has outpaced annual increases in global spending in new drug development, 13.4 percent versus 9.1 percent, according to a 2010 research by the Tufts Center for the Study of Drug Development.

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