Navigation Links
Fast Track: FDA User Fees: Do Faster Review Times Justify the Financial Burden?

The Food and Drug Administration (FDA) recently began requiring applicants to pay significant user fees when filing applications in connection with new medical devices and biologics. Such user fees have long been required for drug-related applications, and now also are required for applications related to devices and biologics. In theory, user fees enable FDA to speed up application review time, b......

Full article >>> ken innovative start-up companies. Moreover, user fees have created a two-tiered review system, where FDA reviews fee-based applications preferentially. Although not every application requires a user fee (and smaller businesses should become familiar with these exceptions), FDA reviews fee-based applications first, before moving to applications that are exempt. Thus, user fees may not only be putt......

Full article >>>
'"/>

Source:wistechnology.com By Morris Waxler, Ph.D. and Gabriel S. Gross 04/22/03


Related biology technology :

1. Fast Track: Topics for Consideration
2. Mission Statement 2003: Do More with Less and Do it Faster!
3. Researchers Push for Faster Drug Development
4. Wisconsin Technology Review - third quarter
5. DM Review announces award finalists
6. Firstlogic a finalist in DM Reviews World Class Solution Awards
7. The (Tech) Economic Year in Review: Signs of Progress Amid Continuing Challenges
8. Mike Rosen Reviews - eXtreme Networking in Madison
9. NY Times Reporter to give Tech Talk in Madison
10. Financial executives to launch Madison chapter
11. Third Wave Reports Third-Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/22/2017)... ALBANY, New York , March 22, 2017 /PRNewswire/ ... market is largely fragmented, states a research report by ... Sanofi S.A., Pfizer Inc., Amgen Inc., and AbbVie Inc., ... market in 2015. The prominent players in this market ... to expand their product portfolio, which is likely to ...
(Date:3/22/2017)... --  Boston Biomedical , an industry leader in the ... stemness pathways, today announced its Board of Directors has ... Officer, effective April 24, 2017. Ms. ... FACP, who has led Boston Biomedical since he founded ... Biomedical has grown from a "garage startup" without technology ...
(Date:3/22/2017)... ... March 21, 2017 , ... Okyanos Cell Therapy has announced ... of their live events series, “Stem Cell Therapy: The Next Phase in the Evolution ... 2013 Stem Cell Research and Therapy Act, Okyanos maintains a mission to ...
(Date:3/22/2017)... ... 21, 2017 , ... Aqua Design Innovations (ADI) has launched ... over $30,000 in the first 40 minutes of crowdfunding. EcoQube is a living ... and affordably, anywhere. , “Simply add fertilized water and in less than 10 ...
Breaking Biology Technology:
(Date:3/7/2017)... Brandwatch , the leading social intelligence company, today announces that it ... insights to support its reporting, help direct future campaigns, and share ... charity will be using Brandwatch Analytics social listening and analytics technology ... the topics and issues that are a priority for its supporters. ... "Until recently we,ve ...
(Date:3/2/2017)... Who risk to be deprived of its ... report: https://www.reportbuyer.com/product/4313699/ WILL APPLE AND SAMSUNG ... Fingerprint sensors using capacitive technology represent a fast growing ... forecasts an increase of 360% of the number of ... fingerprint sensor market between 2014 and 2017 (source : ...
(Date:2/28/2017)... BARCELONA , Spanien, 27. Februar 2017 /PRNewswire/ ... durch Iris-Scan, wird seine erstklassige biometrische Lösung ... Snapdragon™ 835 mit X16 LTE auf dem ... 2. März) am Qualcomm-Stand in Halle 3, ... 835-Prozessor beinhaltet die Sicherheitsplattform Qualcomm Haven™ – ...
Breaking Biology News(10 mins):