White paper addresses new FDA regulations awaiting combo product manufacturers

May 16, 2007 — /PRNewswire/ — AGAWAM, MA — A new, free white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download at www.microtestlabs.com/combinationpaper.

“The combination products market — medical devices embedded with pharmaceutical or biologics components — is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Steven Richter, Ph.D., Microtest president and chief dcientific officer. Richter, a former FDA official, is author of the announced new white paper, “Combination Products: Navigating Two FDA Quality Systems.”

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30% of new products under development today are combo products.

“On the forefront, a new crop of experimental heart stents have been filed with the FDA. The Abbott Labs ‘absorb’ product represents a significant change to existing drug eluting stent technology. Along with new breakthrough technologies like absorb, FDA regulatory centers are struggling with the changes and challenges that these new technologies present,” Richter said.

“For manufacturers, the convergence of devices and drugs or biologics also brings a host of FDA testing guidelines, practices, and regulations unique to the development and production of combination products,” he said.

The challenges are discussed in the new, free white paper, “Combination Products: Navigating Two FDA Quality Systems.” The paper’s contents include: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

Download the free white paper at: www.microtestlabs.com/combinationpaper. Or for more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, MA, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Source: Microtest

Don Goncalves
Tel: +1-781-793-9380
Email: [email protected]

Brandie Gerrish
Tel: +1-781-793-9380
Email: [email protected]
both of Tiziani Whitmyre, Inc., for Microtest


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