Navigation Links
FDA's Lawrence Yu to Participate in Live Video Chat on Question-Based Review (QbR) for Generics on CPhI Pharma Evolution
Date:8/20/2013

NEW YORK, Aug. 20, 2013 /PRNewswire/ -- On Thursday, August 22, at 10:00 a.m. ET, FDA's Lawrence Yu, PhD, will take part in an hour-long video chat on CPhI Pharma Evolution, to discuss the QbR process and address pharma professionals' questions on the initiative and what it means for generic drug manufacturers.

The FDA's Question-Based Review process for generic drugs brings more modern principles from the FDA's cGMPs for the 21st century initiative into CMC evaluations for ANDAs. The process was developed to ensure that what is most critical to final product quality is prioritized in generic drug development, and brings more of the science-based approach found in NDA review to ANDAs. It also aims to have generic manufacturers demonstrate more effective and efficient manufacturing and scale-up approaches, and to integrate the fundamental principles of pharmaceutical QbD into their drug development programs.

Yu, who was instrumental in developing the QbD process, was formerly Director of Science in the FDA's Office of Generic Drugs, is now Acting Deputy Director of its Office of Pharmaceutical Science, and oversees the FDA's Office of New Drug Quality Assessment, Office of Generic Drug Quality Assessment, Office of Biotechnology Products, and Office of Testing and Research.

For more information and to participate in the live video chat, click here: http://www.pharmaevolution.com/video-stream.asp?section_id=3043&doc_id=560782

Contact 
Amy Averbook 
Sr. Marketing Director
UBM DeusM
(917) 743-2693  
averbook@deusm.com

About UBM DeusM
UBM DeusM (www.deusm.com) is an integrated marketing services company owned by UBM plc, targeting the fastest grow
'/>"/>

SOURCE CPhI Pharma Evolution
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Lawrence Livermore engineering team makes breakthrough in solar energy research
2. ViroPharma to Participate in Two December Healthcare Investor Conferences
3. Avanir Pharmaceuticals to Participate in Citi 2012 Global Health Care Conference
4. Medical Experts Who Participated in CSL Behrings Key Issues Dialogue Prefer Albumin for Fluid Management
5. Genomind to Participate in National Alliance on Mental Illness (NAMI) 2012 National Convention
6. Elsevier to Participate in SCOAP3 With the Journals Physics Letters B and Nuclear Physics B
7. Biosim Pharmaceuticals, Manufacturers of Generic ACTHAR, to Participate at Biotech Showcase 2013
8. Vermillion to Participate in Lazard Capital Markets 5th Annual Medical Technology Snowbird Conference on February 27, 2013
9. AVANIR Pharmaceuticals To participate in two conferences in March
10. P&P Optica Invited to Cambridge Innovation Centre for the Canadian Technology Accelerator Program, One of Eight Canadian Life Science Companies Chosen to Participate
11. ViroPharma To Participate In Two May Healthcare Investor Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2014)... August 19, 2014 Sales Horizons, a ... its online sales skills training course to ... , MedTech clinical staff spend the majority of their ... standalone medical center, or physician practice – providing support ... why stop there? Sales Horizons believes clinical staff are ...
(Date:8/18/2014)... Tampa, FL (Aug. 18, 2014) -- A new ... South Florida (USF) Morsani College of Medicine and ... the life-threatening complications of interventional cardiovascular disease treatment. ... model that the novel molecular therapy could selectively ... healing following a medical procedure using a balloon ...
(Date:8/18/2014)... Md. , Aug. 18, 2014 /PRNewswire/ ... maker of advanced consumer medical devices said ... was interviewed by CEOLIVE.TV as part ... The entire interview is available at ... Dr. Kotak explains to investors the unique ...
(Date:8/18/2014)... efficiency and data storage may someday run ... polarizations to read and write digital information, ... technology. But ferroelectrics must first overcome a ... habit of "forgetting" stored data. , ... Energy,s Brookhaven National Laboratory have discovered nanoscale ...
Breaking Biology Technology:Sales Horizons Launches a New Online Sales Training Course for MedTech Clinical Staff to Develop Their Sales Skills 2Sales Horizons Launches a New Online Sales Training Course for MedTech Clinical Staff to Develop Their Sales Skills 3Selective therapy may improve artery repair after interventional cardiovascular procedures 2Selective therapy may improve artery repair after interventional cardiovascular procedures 3BioElectronics EVP Dr. Deepak Kotak Interviewed on CEO Live 2BioElectronics EVP Dr. Deepak Kotak Interviewed on CEO Live 3Promising ferroelectric materials suffer from unexpected electric polarizations 2Promising ferroelectric materials suffer from unexpected electric polarizations 3Promising ferroelectric materials suffer from unexpected electric polarizations 4
... Merge eMed updates eFilm Workstation , Milwaukee, Wis. ... Merge Healthcare company and a leading medical imaging software ... Workstation 2.1 and its plug-in Advanced Visualization and Clinical ... widely used desktop diagnostic imaging software includes customer-driven updates ...
... Norlight Telecommunications has adopted an unconventional ... number of technical jobs. The Wisconsin-based provider of customized ... an external referral bonus program to reward anyone who ... vacancies. , ,Norlight's is encouraging others to refer ...
... Wis. A new report suggests Wisconsin is slowly ... as judged by indicators such as producing patents, investing in ... question: Why are we improving? , ,There is no ... provided were not swamped in a sea of global ...
Cached Biology Technology:Heres why Wisconsins tech economy indicators are up 2Heres why Wisconsins tech economy indicators are up 3
(Date:8/19/2014)... from fish purchased at retail seafood counters in ... mislabeling can expose consumers to unexpectedly high levels ... "substitutions"which falsely present a fish of the same ... most dangerous mislabeling offense, according to new research ... "Accurate labeling of seafood is essential to allow ...
(Date:8/19/2014)... Two Northwestern University scientists have identified a biomarker ... aggressive carcinoma that is resistant to many types ... provides a smart target for new therapeutics designed ... breast cancer patient data taken from The Cancer ... Robert W. Tell used powerful computational and bioinformatics ...
(Date:8/19/2014)... -- Scientists at the Houston Methodist Research Institute have ... cells using a pipette -- a common laboratory tool ... and preliminary test results in a recent issue of ... , "Studying single cells and their unique functions has ... department. faculty member Lidong Qin, Ph.D., the project,s principal ...
Breaking Biology News(10 mins):Seafood substitutions can expose consumers to unexpectedly high mercury 2Seafood substitutions can expose consumers to unexpectedly high mercury 3Biomarker in an aggressive breast cancer is identified 2Biomarker in an aggressive breast cancer is identified 3Moving single cells around -- accurately and cheaply 2
... urban areas face more predators than do those in rural ... nest robbers. A six-year study conducted in 19 central ... rural areas that had higher numbers of nest predators such ... of nest survival. But there was no relation between ...
... Across the globe, the diversity of plant and animal species ... Equator but surprisingly that rule isn,t true for soil bacteria, ... Paul Grogan. "It appears that the rules determining the ... rules for bacteria," says Professor Grogan. The finding is ...
... the National Academy of Engineering and National Research Council ... the Deepwater Horizon explosion and oil spill will hold ... head of safety and operations for BP, and other ... Also on the agenda are Thomas Roth, vice ...
Cached Biology News:More predators doesn't equal more danger for urban bird nest 2
sterile filtered, off the clot, all male donors, Total Protein: 4.5 to 8.5 g/dl...
Recombinant Mouse MMP-9, CF...
Human/Mouse/Rat JNK Pan Specific Affinity Purified PAb...
Blue Standard is 3-cyano-7-hydroxycoumarin....
Biology Products: