Navigation Links
White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers
Date:12/1/2008

AGAWAM, Mass., Dec. 1 /PRNewswire/ -- Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics componentsis expected to become even more challenging and complex.

"Given the convergence of technologies, combination product manufacturers - often either medical device or pharmaceutical companies 'crossing over to the new market' - must ensure their products meet cGMP practices as well as pass muster with the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and The United States Pharmacopeia (USP)," said Steven Richter, Ph.D., President & Chief Scientific Officer of Microtest Laboratories, and a former FDA official.

"The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements," said Richter. "The process, already complex, is likely to become even more so," he warned.

In fiscal 2007, the FDA received 333 original applications for combination products, a 42 percent increase over 2006. The FDA itself reports that combination product submissions "raise challenging regulatory, policy, and review management issues... [that] can impact the regulatory processes of all aspects of the product life cycle."

In the free white paper, "Combination Products: Navigating Two FDA Quality Systems," Richter provides a helpful overview of the challenges facing combination product manufacturers. Download the white paper at www.microtestlabs.com/combinationpaper.

"For manufacturers, the convergence of devices and drugs or biologics brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products - and generally outside their original core competence in achieving regulatory approvals as either a medical device or pharmaceutical manufacturer," he said.

In the white paper, Richter discusses: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

According to the FDA, some estimate the total global value of the drug-device combination products market will grow to $11.5 billion in 2010, up more than double from $5.4 billion in 2004.

Download the free white paper at: www.microtestlabs.com/combinationpaper. 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, and biotechnology industries. Based in Agawam, Massachusetts, 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.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D: https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. New White Paper Details Strategies for Biotechnology Companies to Improve EH&S Compliance
2. Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
3. New White Paper Details Six Steps to Investigate and Prevent Laboratory Accidents
4. Microtest Offers Free White Paper: Virus Testing for Biological Products: Partnering With a Contract Lab
5. Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
6. Medco Chooses AllPoints at Anson in Whitestown, Indiana as Site for the Worlds Largest, Most-Advanced Automated Pharmacy
7. Free White Paper Helps Biotech Laboratories Maintain a High Level of Infection Control
8. Free White Paper Available for Clinical Laboratory Managers: Effectively Isolating Anaerobic Bacteria
9. White Paper Details Infection Control Challenges Hospitals Must Address During Construction
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Marteks lifesDHA(TM) Now Featured in Two New Flavors of Rachels(R) Wickedly Delicious Yogurt from WhiteWave Foods
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... Parallel 6 , ... announced today the Clinical Reach Virtual Patient Encounter CONSULT module which enables ... the physician and clinical trial team. , Using the CONSULT module, patients and physicians ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... for Amgen, will join the faculty of the University of North Carolina ... professor of strategy and entrepreneurship at UNC Kenan-Flagler, with a focus on the ...
(Date:6/27/2016)... --  Ginkgo Bioworks , a leading organism design ... awarded as one of the World Economic Forum,s ... innovative companies. Ginkgo Bioworks is engineering biology to ... in the nutrition, health and consumer goods sectors. ... including Fortune 500 companies to design microbes for ...
(Date:6/24/2016)... June 24, 2016 Epic Sciences unveiled ... cancers susceptible to PARP inhibitors by targeting homologous ... (CTCs). The new test has already been incorporated ... multiple cancer types. Over 230 clinical ... response pathways, including PARP, ATM, ATR, DNA-PK and ...
Breaking Biology Technology:
(Date:4/28/2016)... BANGALORE, India , April 28, 2016 ... subsidiary of Infosys (NYSE: INFY ), and Samsung ... global partnership that will provide end customers with a ... and payment services.      (Logo: http://photos.prnewswire.com/prnh/20130122/589162 ... for financial services, but it also plays a fundamental part ...
(Date:4/26/2016)... -- Research and Markets has announced the ...  report to their offering.  , ,     (Logo: ... forecast the global multimodal biometrics market to grow ... 2016-2020.  Multimodal biometrics is being implemented ... healthcare, BFSI, transportation, automotive, and government for controlling ...
(Date:4/15/2016)... -- Research and Markets has announced the ...  report to their offering.  ,      ... gait biometrics market is expected to grow at ... Gait analysis generates multiple variables such ... compute factors that are not or cannot be ...
Breaking Biology News(10 mins):