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 f
'/>"/>

SOURCE Microtest
Copyright©2007 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. 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:12/15/2014)... 2014 Organovo Holdings, Inc. (NYSE MKT: ... delivering breakthrough 3D bioprinting technology,  today celebrated continued ... its exVive3D TM Human Liver Tissue.  The ... commercial release on November 18, has been recognized ... awards for innovation. Most recently, on ...
(Date:12/15/2014)... Limited (NASDAQ GS: SEED) (" Origin ", or the " ... China , today announced that the Company will ... 2014, before the market opens on Thursday, January 8, 2015. ... 8, 2015, at 8:00 a.m. ET / 9:00 p.m. ... participate in the call, please dial +1-888-346-8982 in ...
(Date:12/13/2014)... 2014 CanDiag, Inc., a University of ... changed its name to OncoTab, Inc. , “The ... we are today,” said CEO and Chief Science Officer, ... beyond breast cancer diagnostics to include imaging and therapies, ... evolution.” , Founded in 2011 by Dr. Mukherjee, an ...
(Date:12/13/2014)... 2014 Clarassance, a privately held clinical-stage ... name: Therabron Therapeutics , Inc. The new name ... type of structure in the lungs similar to branches ... develop novel protein therapeutics for the treatment of respiratory ... change the name to mark the company's escalation into ...
Breaking Biology Technology:Organovo Celebrates a Positive 2014 Reception of its exVive3DTM Human Liver Tissue Product 2Organovo Celebrates a Positive 2014 Reception of its exVive3DTM Human Liver Tissue Product 3Origin Agritech Limited to Announce Fiscal 2014 Annual Financial Results on January 8th, 2015 2Origin Agritech Limited to Announce Fiscal 2014 Annual Financial Results on January 8th, 2015 3CanDiag Inc. Expands Product Scope Under a New Name: OncoTab, Inc. 2Maryland-based Biotech Company's Path Forward in Treating Respiratory Diseases Sparks Name Change 2
... VRUS ) management will present at the Morgan ... 2008 to May 2,2008 at the Ritz-Carlton Key Biscayne ... provide an overview of the,company and participate in a ... 2008 at 3:40 PM (ET) in the Plaza,Ballroom., ...
... AANS/CNS Section on Tumors,and BrainLAB today announced the ... MD, from the People,s Republic of China, was,awarded ... Bone Marrow,Derived Mesenchymal Stem Cells in Brain Tumor ... a $50,000 stipend to conduct research in his,proposed ...
... 24 The Board of,Directors of Shire plc ... specialty,biopharmaceutical company, announces today that Michael Rosenblatt M.D.,will ... immediate effect., Dr Rosenblatt is the Dean ... was previously Professor of Medicine at Harvard,Medical School ...
Cached Biology Technology:Pharmasset to Present at the Morgan Stanley Global Healthcare Conference on Wednesday, April 30th 2AANS/CNS and BrainLAB Announce Winner of 2008 International Research Fellowship 2AANS/CNS and BrainLAB Announce Winner of 2008 International Research Fellowship 3Dr Michael Rosenblatt Appointed Non-Executive Director at Shire 2Dr Michael Rosenblatt Appointed Non-Executive Director at Shire 3Dr Michael Rosenblatt Appointed Non-Executive Director at Shire 4
(Date:12/15/2014)... DUBLIN , Dec. 12, 2014 Research ... announced the addition of the "Global Facial ... http://photos.prnewswire.com/prnh/20130307/600769 ... the identification of individuals. Facial recognition system measures ... as nose, jaw edges, mouth, and the distance ...
(Date:12/10/2014)... YORK , Dec. 8, 2014 You,ve been ... banking account but can,t remember your password, site key or ... Who was your first grade teacher? Today, ... the app that will finally put an end ... – 1U TM . 1U leverages a user,s ...
(Date:12/10/2014)...     Jifflenow ...   Jifflenow, a leading provider ... business-to-business (B2B) events, today announced a partnership with ... communication (NFC), Bluetooth low energy (BLE), and cloud-based ... Jifflenow will integrate its meeting scheduling ...
Breaking Biology News(10 mins):Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 2Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 3
... international team of researchers led by Daniel J. ... for Translational Medicine and Therapeutics, has received a ... to study the molecular genetics of atherosclerotic cardiovascular ... Genes Associated with Plasma Lipids and Cardiovascular Disease," ...
... A cat regularly vomiting hairballs or refusing to eat probably ... might say. There is a good chance that the cat ... in its environment, new research suggests. Healthy cats were ... vomit frequently and leave waste outside their litter box in ...
... engineering faculty at Oregon State University have invented a ... will be particularly useful for cleanup of sites with ... less expensive. A patent has been granted on ... production of devices will begin soon. The advance has ...
Cached Biology News:Penn Medicine researcher receives $6 million grant for cardiovascular disease study 2Even healthy cats act sick when their routine is disrupted 2Even healthy cats act sick when their routine is disrupted 3Even healthy cats act sick when their routine is disrupted 4Even healthy cats act sick when their routine is disrupted 5New technology to speed cleanup of nuclear contaminated sites 2
5,6 Carboxyfluorescein is conjugated to BSA (bovine serum albumin) protein through amide bonds....
2,4,6-Trinitrophenyl hapten is conjugated to Bovine Serum Albumin protein through lysine by amide bonds....
... by R. Edwards (1996) • ... types of immunoassays, including RIA, ... and on the photoluminescent and ... information is also given on ...
EoProbe Eosinophil Staining Kit, 1 Kit...
Biology Products: