Navigation Links
Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
Date:12/4/2007

AGAWAM, Mass., Dec. 4 /PRNewswire/ -- 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 http://www.microtestlabs.com/combinationpaper.

While combination products are experiencing dramatic growth, the convergence of drug/biologics and devices brings a host of regulatory challenges. Manufacturers must ensure their products meet cGMP practices as well as pass muster with the FDA, ISO, and USP.

Steven Richter, Ph.D., Microtest President & Chief Scientific Officer, addresses the critical issues associated with this complex process, including defining the FDA's regulatory framework, reviewing developments in FDA thinking, and identifying future considerations in developing effective quality assurance systems.

"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 Richter, who is author of the announced 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.

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

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: http://www.microtestlabs.com/combinationpaper. For more information visit Microtest on the Web at http://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, 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 http://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. http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2007 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. 454 Sequencing(TM): Science Paper Suggests That Structural Variation Plays an Important Role in Genetic Variation
6. Video: New Survey Finds Technology Plays a Critical Role in Lives of People with Multiple Sclerosis, Yet Many Are Not Using it to Overcome Disease-Related Challenges
7. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
8. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
9. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
10. IsoTis Receives FDA Clearance for Accell Family of Products
11. MedImmune Licenses Reverse Genetics Technology to Novartis for Use in Influenza Vaccine Development and Production
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... AMRI, a ... biotechnology industries to improve patient outcomes and quality of life, will now be ... are being attributed to new regulatory requirements for all new drug products, including ...
(Date:10/11/2017)... ... 2017 , ... At its national board meeting in North ... the co-founder, CEO and chief research scientist of Minnesota-based Advanced Space Technology and ... ARCS Alumni Hall of Fame . ASTER Labs is a technology development ...
(Date:10/11/2017)... ... ... a basic first aid supply for any work environment, but most personal eye wash can ... a dangerous substance enters both eyes? It’s one less decision, and likely quicker response time ... , “Whether its dirt and debris, or an acid or alkali, getting anything in your ...
(Date:10/11/2017)... Md. (PRWEB) , ... October 11, 2017 , ... ... digital pathology, announced today it will be hosting a Webinar titled, “Pathology is ... Advanced Pathology Associates , on digital pathology adoption best practices and how Proscia ...
Breaking Biology Technology:
(Date:10/4/2017)... Solutions, a global clinical research organization (CRO), announces the launch of ... 4, 2017. Shadow is designed to assist medical writers and biometrics ... the European Medicines Agency (EMA) in meeting the requirements for de-identifying ... ... ...
(Date:6/23/2017)... and ITHACA, N.Y. , ... and Cornell University, a leader in dairy research, today ... bioinformatics designed to help reduce the chances that the ... the onset of this dairy project, Cornell University has ... for Sequencing the Food Supply Chain, a food safety ...
(Date:5/6/2017)... , May 5, 2017 ... just announced a new breakthrough in biometric authentication ... exploits quantum mechanical properties to perform biometric authentication. These ... smart semiconductor material created by Ram Group and ... finance, entertainment, transportation, supply chains and security. Ram ...
Breaking Biology News(10 mins):