Navigation Links
Two ISPE Studies Cited in FDA Statement to Congress
Date:12/20/2013

Tampa, Fla. USA (PRWEB) December 20, 2013

Two recent ISPE studies were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug Evaluation and Research (CDER), in her statement associated with her testimony to the U.S. Congressional Committee on Oversight and Government Reform’s Subcommittee on Energy Policy, Health Care and Entitlements.

In the December 12 hearing, “FDA Check Up: Drug Development and Manufacturing Challenges,” Dr. Woodcock stated that novel manufacturing technologies could, with the proper strategies, revitalize pharmaceutical manufacturing in the U.S., thereby reducing dependence on potentially vulnerable foreign-sourced materials. Dr. Woodcock reported that the FDA has been working in collaboration with industry experts to stimulate the development of new manufacturing technologies capable of responding rapidly to changes in demand.

During her testimony, Dr. Woodcock strongly advocated the use of Quality by Design (QbD) to enhance development capability and reduce manufacturing costs while ensuring that patients receive high-quality drug products. As evidence, Dr. Woodcock cited the results of a survey conducted by the ISPE United Kingdom Affiliate’s Process Analytical Technology (PAT) Community of Practice, in which companies using QbD reported benefits such as improved product quality and process robustness, increased process capability, greater speed and reliability to market, as well as significant cost benefits.

QbD also can increase manufacturing capability and a firm’s ability to identify the root causes of manufacturing failures, said Dr. Woodcock, referencing ISPE’s Drug Shortages study and naming inadequate manufacturing capability as a frequent cause of critical drug supply shortfalls, particularly in the areas of lyophilization (freeze-drying) associated with the production of sterile products.

“We applaud the FDA’s collaborative approach to the deve
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. Adaptive Biotechnologies and Collaborators Present 16 Studies Demonstrating Clinical Significance of ImmunoSequencing at 55th Annual Meeting of the American Society for Hematology
2. Elsevier Announces the Launch of Open Access Journal: Case Studies in Construction Materials
3. Associates for Breast and Prostate Cancer Studies Honors Ann-Margret, Robert Wagner and Bill and Roseann Patterson at 24th Annual The Talk of the Town Gala
4. Successful Pediatric Studies: Key Study Design and Operational Considerations, a New Webinar Presented by Premier Research and Xtalks
5. Enteroviruses Cause Type 1 Diabetes; New Studies Support Dr. Hanan Polansky’s Microcompetition Theory
6. Drug Discovery Using Natural Products - Optimization Studies of Inhibitors of Glucan Synthesis as Anti-Fungal Agents, New Life Science Webinar Hosted by Xtalks
7. Acacia Pharma Initiates Pivotal Phase 3 Studies with APD421 in Post-Operative Nausea & Vomiting (PONV)
8. Sciedu Press Launches New Journal for Management and Orgnaization Studies
9. Elusys Releases New Data On Anthrax Anti-Toxin Administered Via Intramuscular Injection From Three Recent Animal Studies
10. AACC Pilot Studies Begin to Measure What Is Normal in Childrens Development
11. Addressing Scientific and Regulatory Challenges for Abuse Liability Studies, New Life Science Webinar Hosted by Xtalks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2015)... May 26, 2015   PDI , a ... announced that Oakwood Healthcare in Dearborn, ... winning entry in Delivering the Difference ... display excellence in building collaborative relationships between infection ... healthcare facilities.  Oakwood Healthcare,s infection ...
(Date:5/26/2015)... (PRWEB) May 26, 2015 Leading ... beginning of a long-term relationship with Veterinary Growth ... of its members to provide access to vital ... pleased to count VGP as a dedicated partner ... dog patients nationwide. Concentrating and using stem cells ...
(Date:5/26/2015)... MENLO PARK, Calif. , May 26, 2015 /PRNewswire/ ... focused on the emerging field of regenerative medicine, today ... issued in June 2014 were exercised prior to their ... to the Company of $11.7 million. "We ... Pedro Lichtinger , President and CEO of Asterias. "This ...
(Date:5/26/2015)... Ill. , May 26, 2015  AbbVie ... announced today that it has completed the acquisition ... presence in oncology. Pharmacyclics is a leader in ... first-in-class BTK-inhibitor used to treat hematological cancers, a ... shared expertise, combined with AbbVie,s broad late-stage oncology ...
Breaking Biology Technology:PDI Announces Winner in Delivering the Difference Contest 2PDI Announces Winner in Delivering the Difference Contest 3VetStem Biopharma & Veterinary Growth Partners Join Forces to Increase Member Veterinary Hospital Revenue Through Cutting Edge Medical Offering 2VetStem Biopharma & Veterinary Growth Partners Join Forces to Increase Member Veterinary Hospital Revenue Through Cutting Edge Medical Offering 3Asterias Biotherapeutics Receives $11.7 Million in Proceeds from Exercise of Warrants 2Asterias Biotherapeutics Receives $11.7 Million in Proceeds from Exercise of Warrants 3AbbVie Completes Acquisition of Pharmacyclics 2AbbVie Completes Acquisition of Pharmacyclics 3AbbVie Completes Acquisition of Pharmacyclics 4AbbVie Completes Acquisition of Pharmacyclics 5AbbVie Completes Acquisition of Pharmacyclics 6
... 17 Simbionix, the world,s leading,developer of medical simulation ... for distribution of Simbionix,s simulators and related,products. , ... of Johnson & Johnson, operates in,Russia, the Ukraine, and ... & Johnson LLC will have exclusive rights to distribute,Simbionix,s ...
... Growing Demand , ... Arlington, Va. (PRWEB) April 16, ... meet the growing demand for food, biofuels and materials if public ... take a more holistic approach to the solution, William S. ...
... Understanding the Fundamental Mechanism of Angiogenesis is More ... AAmgen Launches Angiogenesis Website THOUSAND OAKS, Calif., April ... today announced that results from several preclinical studies ... at the 2009 American Association for Cancer Research ...
Cached Biology Technology:Simbionix and Johnson & Johnson LLC Announce a Distribution Agreement for Russia and the CIS Countries 2DuPont Leader: Agriculture is Up to Global Productivity Challenge 2DuPont Leader: Agriculture is Up to Global Productivity Challenge 3DuPont Leader: Agriculture is Up to Global Productivity Challenge 4Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR 2Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR 3Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR 4Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR 5Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR 6Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR 7
(Date:4/27/2015)... Apr. 27, 2015 NXT-ID, Inc. (NASDAQ: ... company focused on the growing mobile commerce market, announces ... pre-order customers the first week of May, 2015 and ... of May. Gino Pereira , ... for the company as Wocket® enters the consumer market. ...
(Date:4/21/2015)... High crime rate, increasing ... access control systems market in Saudi Arabia ... published report by TechSci Research " Saudi Arabia Access Control ... systems market in Saudi Arabia ... control systems market in the Kingdom is growing at ...
(Date:4/20/2015)... 20, 2015 The announcement comes ... Glenbeigh Records Management (GRM), Ireland,s foremost ... Bank. Having built up an impressive track record of clients ... player within the records management sector in Dubai ... is GCC staffbase and employ a further eight staff members ...
Breaking Biology News(10 mins):Wocket, the Smartest Wallet You Will Ever Own, Announces Shipment to Pre-order Customers 2Wocket, the Smartest Wallet You Will Ever Own, Announces Shipment to Pre-order Customers 3Saudi Arabia Access Control Systems Market to Touch USD1.2 Billion by 2020 Says TechSci Research 2Saudi Arabia Access Control Systems Market to Touch USD1.2 Billion by 2020 Says TechSci Research 3Glenbeigh Records Management Wins Contract With Dubai Islamic Bank 2Glenbeigh Records Management Wins Contract With Dubai Islamic Bank 3
... The International HapMap Project was initiated with the primary ... basis for human diseases. To coordinate with the ... journal Genome Research is announcing a special ... to studies using these data to provide insight into ...
... with the primary goal of facilitating medical studies and ... coordinate with the journal Nature 's publication describing ... announcing a special issue entitled "Human Genome Variation," which ... provide insight into human biology and disease. , ...
... drug designAs part of a $4.88 million grant from ... University of Rochester Medical Center will join a team ... a living cell. By wiring diagram, researchers mean a ... their function, but also of the interplay between them. ...
Cached Biology News:Housecat-sized Siberian tiger cubs get collared 2Housecat-sized Siberian tiger cubs get collared 3Housecat-sized Siberian tiger cubs get collared 4Studies on human genome variation provide insight into disease 2Studies on human genome variation provide insight into disease 3Studies on human genome variation provide insight into disease 4New study to explore cellular circuitry 2New study to explore cellular circuitry 3