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

rs, 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

Page: 1 2

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:12/19/2014)...  Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... a privately held company based in ... a big data platform for centralized management and ... proprietary on-market Genomic Management Solution, Bina-GMS 1 , ... fast and scalable analyses to maximize the value ...
(Date:12/19/2014)... 2014 BioPlus Specialty Pharmacy ... pharmacies, has an expanded team of Regional Pharmaceutical ... for prescriber offices in their regions, with specific ... have a variety of Regional Pharmaceutical Care Liaisons ... in hepatitis C help prescribers understand all the ...
(Date:12/19/2014)... Reports from CDC show approximately 117 ... or more chronic health conditions - including cardiovascular disease, ... of these diseases, but may not eliminate the severe ... implanted nerve stimulation devices today offer relief, they require ... induce side effects. , To eliminate the need ...
(Date:12/19/2014)... 18, 2014 With only 2 weeks ... special on Sartorius Biohit products . The product specials ... Picus Electronic Pipette Trade-in Program, and free pipette tips. ... officers around the world. They are ideal for lab ... include:, ,     Full volume range of 0.1 ...
Breaking Biology Technology:Roche acquires Bina Technologies and enters the genomic informatics market 2Roche acquires Bina Technologies and enters the genomic informatics market 3BioPlus Specialty Pharmacy Expands ‘Regional Pharmaceutical Care Liaison’ Team 2BioPlus Specialty Pharmacy Expands ‘Regional Pharmaceutical Care Liaison’ Team 3Draper Wins GSK Funding for Smaller, Smarter Implantable Devices 2Major Pipette Distributor Pipette.com Announces Sartorius Year End Specials 2
... Germany and OXFORD, England, November 28, Evotec AG ... Polywka and Dr Klaus Maleck have been appointed ... Officer and,Chief Financial Officer., Jorn Aldag, President ... extremely pleased to announce the addition of Dr ...
... Nov. 27 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals,Inc. (NASDAQ: ... and,medical device company, is scheduled to participate in ... being held December 2 - 4 in Orlando, ... will give a 15-minute,formal presentation followed by a ...
... listing includes over 4,000 antibody products with documented ... ... Sigma-Aldrich(TM) (Nasdaq:,SIAL) is pleased to announce the new 2007-2008 ... (Photo: http://www.newscom.com/cgi-bin/prnh/20071127/AQTU011 ), The 320-page Sigma Antibodies ...
Cached Biology Technology:Evotec Appoints Mario Polywka and Klaus Maleck to the Management Board 2Evotec Appoints Mario Polywka and Klaus Maleck to the Management Board 3Evotec Appoints Mario Polywka and Klaus Maleck to the Management Board 4Sigma-Aldrich Announces Launch of a New Antibodies Catalog 2Sigma-Aldrich Announces Launch of a New Antibodies Catalog 3
(Date:12/19/2014)...   LaunchKey , the first decentralized mobile authentication ... of Things era, today announced the close of $3 ... led by Metamorphic Ventures with participation from ENIAC Ventures, ... others.  LaunchKey has raised $4 million to date, and ... and bring LaunchKey to market in 2015. ...
(Date:12/17/2014)... DUBLIN , Dec. 16, 2014 Research ... announced the addition of the "Global Chemical ... http://photos.prnewswire.com/prnh/20130307/600769 ... is the increasing demand for medical sensors in ... patient data for quick and correct diagnosis during ...
(Date:12/11/2014)... -- That blood pressure plays a role in human health has ... term for high blood pressure – was first described as ... that,s used in measuring blood pressure was invented in 1896. ... hypertension, its triggers and its effects. In fact, recent findings ... best ways to treat it. For example, a ...
Breaking Biology News(10 mins):LaunchKey Raises $3 Million in Additional Funding Led by Metamorphic Ventures 2LaunchKey Raises $3 Million in Additional Funding Led by Metamorphic Ventures 3Global Chemical Sensor Market 2015-2019: Key Vendors are Abbott Laboratories, Bayer, Hoffmann La-Roche, Johnson & Johnson, NGK Spark Plugs and Robert Bosch 2Research points to need for new approaches to treatment of high blood pressure 2Research points to need for new approaches to treatment of high blood pressure 3Research points to need for new approaches to treatment of high blood pressure 4
... in the two chromosomes has given scientists a break ... College of Georgia researchers report. It,s also helped ... no sense of smell, said Dr. Lawrence C. Layman, ... and Genetics. The WRD11 gene interacts with a ...
... The National Institute of General Medical Sciences (NIGMS) ... of Yeshiva University a five-year, $30 million grant to ... important proteins. "Determining the structures of proteins is ... biological processes as well as in disease pathways," says ...
... An Australian study of identical twins shows that a rare ... mutation that occurs in the embryo, and not necessarily passed ... University of Melbourne and Austin Health and published in the ... Director of the Comprehensive Epilepsy Program at Austin Health and ...
Cached Biology News:Chromosomal break gives scientists a break in finding new puberty gene 2Chromosomal break gives scientists a break in finding new puberty gene 3Einstein receives $30 million to study protein form and function 2Einstein receives $30 million to study protein form and function 3Einstein receives $30 million to study protein form and function 4
... salt solution. It is routinely used as an ... blood at refrigerator temperatures for approximately 10 weeks.1 ... collected into a container of this product and ... in a refrigerator at 2-8 C for 2 ...
... OligoMix or individual RNA sequences from high throughput ... small RNAs from LC Sciences. These products provide ... millions) of DESIGNED sequences delivered in a microtube ... containing a single verified RNA sequence. This is ...
... Chromatograph/Mass Spectrometer, utilizing many of the ... offers high throughput and excellent productivity, ... ratio. Like the GCMS-QP2010 Plus, the ... for optimum separation, 20 temperature ramps, ...
... Assay Kit contains all reagents necessary to ... lineage, as determined by staining for mineralization. ... necessary reagents and a protocol for quantifying ... product is useful for studying the effects ...
Biology Products: