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 manufacture
'/>"/>

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:5/6/2015)...   University of Maryland (UM) Ventures and ... of an exclusive option by Biomecite Diagnostics for the ... diagnostics to detect inflammatory bowel diseases (IBD), such as ... Florian Fricke and James White developed ... of Maryland School of Medicine,s Institute for Genome Sciences ...
(Date:5/6/2015)... (PRWEB) May 06, 2015 Histogen, ... on the products of cells grown under simulated ... 105F immunomodulatory treatment candidate for melanoma during the ... taking place May 6-9, 2015 in Atlanta, GA. ... cells produce a soluble material with anti-oncologic properties, ...
(Date:5/5/2015)... 5, 2015 /PRNewswire/ - Aptose Biosciences Inc. (NASDAQ: APTO, TSX: ... for the three months ended March 31, 2015 and ... are in Canadian dollars. Effective July ... from May 31 to December 31. As a result ... is for the three months ended March 31, 2015, ...
(Date:5/5/2015)... DUBLIN , May 05, 2015 /PRNewswire/ ... ) has announced the addition of the ... report to their offering. Macromolecules ... acids undergo separation or are broken into ... biotechnological products. This separation requires various advanced ...
Breaking Biology Technology:Biomecite Diagnostics Signs Option Agreement with UM Baltimore to Develop Tools to Detect Inflammatory Bowel Diseases 2Biomecite Diagnostics Signs Option Agreement with UM Baltimore to Develop Tools to Detect Inflammatory Bowel Diseases 3Novel Immunomodulatory Treatment Induces Apoptosis in Melanoma 2Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 2Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 3Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 4Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 5Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 6Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 7Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 8Global Separation Systems Market in Biotechnology 2015-2019 - Trends and Forecasts for the $28 Billion Market 2
... Syndax Pharmaceuticals, Inc. announced today that data ... entinostat, a novel, oral small molecule inhibitor of class ... in patients with relapsed or refractory Hodgkin,s lymphoma (HL).  ... 6:00 to 8:00 PM PT at the American ...
... ICBS Ltd., (OTCPK: ICBT), updates shareholders. As you ... we feel have the greatest chance of success. They are ... each instance, ICBS has funded the purchase of equipment and ... goals. We have paid for all of their expenses in ...
... 2011  CeNeRx BioPharma, Inc., a clinical stage company ... the central nervous system (CNS), today announced completion ... Soros Biopharmaceutical Fund, L Capital Partners, Pappas Ventures ... CeNeRx plans to use the proceeds to complete ...
Cached Biology Technology:Entinostat Demonstrates Activity in Hodgkin's Lymphoma 2Entinostat Demonstrates Activity in Hodgkin's Lymphoma 3Entinostat Demonstrates Activity in Hodgkin's Lymphoma 4Entinostat Demonstrates Activity in Hodgkin's Lymphoma 5ICBS, Update for Shareholders. 2ICBS, Update for Shareholders. 3CeNeRx BioPharma Completes $4.85 Million Financing 2CeNeRx BioPharma Completes $4.85 Million Financing 3
(Date:4/2/2015)... April 2, 2015 In ... by far outperforms the strongest competitors, showing outstanding ... accuracy, the system is capable of a throughput ... proves up to be ten times faster than ... runner-up performance.      (Photo: http://photos.prnewswire.com/prnh/20150402/738673-a ...
(Date:4/1/2015)... --  Medisafe ™, the leading global medication management platform ... and Android smartphones and tablets, announces today ... to allow patients to track and correlate their adherence ... will be able to visualize in real-time how taking ... as glucose levels and blood pressure. "Patients ...
(Date:3/24/2015)... Research and Markets ( http://www.researchandmarkets.com/research/hdgz7h/global_iris ) ... Recognition Market 2015-2019" report to their offering. ... to grow at a CAGR of 23.5 percent over ... present scenario and the growth prospects of the Global ... the market size, the report considers the revenue generated ...
Breaking Biology News(10 mins):DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 2DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 3Medisafe Announces Launch of Biometric Integration, Enabling Patients to Stay Adherent to Their Meds and See Tangible Health Results 2Global Iris Recognition Market 2015-2019 with 3M Cogent, Bioenable Technologies, Cross Match Technology, Iris ID Systems & Safran Dominating 2
... than boys. Every third child of school age prefers soft ... fish and do not think of themselves as being fussy ... taste differently.The findings of the world,s largest study so far ... and what they like have now been published. The study ...
... Society of Japan (PSJ) has chosen Springer to publish ... , starting in January 2009 with Volume 59, Number ... Society and Medical Tribune Co. Ltd. The journal ... includes such publications as Experimental Brain Research ...
... Medical Center have discovered that older people use their ... storing memories, particularly those associated with negative emotions. ... of Psychological Science , is a novel look ... Older adults, average age 70, and younger adults, average ...
Cached Biology News:Girls have superior sense of taste to boys 2Girls have superior sense of taste to boys 3Girls have superior sense of taste to boys 4Springer and the Physiological Society of Japan sign publishing agreement 2Old and young brains rely on different systems to remember emotional content 2
ANTI END CEL LUNG AG...
For the quantitative determination of canine Interleukin 10,(IL-10) concentrations in cell culture supernates, canine serum,and plasma....
EGTA, 50 g. Ethylene glycol-O,O-bis-[2-amino-ethyl]-N,N,N,N,-tetraacetic acid.Assay: > 99.0%. Category: Nucleotides & Enzymes & Biochemicals, Ultrapure Biochemicals ....
RAT ANTI RAT RT1Au (CLASS I POLYMORPHIC) Immunogen: AO lymphoid cells...
Biology Products: