Navigation Links
Fourth Medical Innovation Impact Index Issued by Fairleigh Dickinson University’s Initiative for Patient-Centered Innovation (iPCI)
Date:8/26/2015

The fourth Medical Innovation Impact Index (MI3) Alert considers the 2017 reauthorization of both PDUFA and MDUFA (Medical Device User Fee Amendments) for which discussions and hearings are being scheduled. User fees received a score of -3 (range -10 to +10) for their impact on medical innovation by the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Rothman Institute of Innovation and Entrepreneurship.

The purpose of user fees is to provide additional funds to the FDA to process new product applications more expeditiously. PDUFA and MDUFA established target time frames within which new products are to be reviewed. Unfortunately, FDA performance is not in line with the review time frames established by user fees. For example, in 2013, the median approval times for drugs was 304 days – this means that approval times exceed the PDUFA goal of 10 months for 50% of applications.

Moreover, in an effort to meet review deadlines, at least for some new products, PDUFA amendments have ushered-in a rapidly-expanding series of regulatory incentives for niche areas of “high unmet medical need.” This has created a very disjointed, cumbersome, and exploding body of law for FDA reviewers and drug developers to master. Without proper time for these to mature and settle-into practice, great uncertainty and inconsistency with respect to their application has ensued. Worse, drug developers are preferentially directing their efforts to niche diseases to avail themselves to the regulatory incentives contained in PDUFA, neglecting other diseases that affect huge populations of patients. This is not helpful to medical innovation and not good for patients.

The Medical Innovation Impact Index (MI3) is a succinct, real world analysis and scoring system based on interviews with legal and medical experts who interact with government agencies regularly in the review of new products in development. The purported benefits and potential positive impacts on medical innovation are listed and scored zero to +5, based on the likelihood of achieving these objectives; the unintended consequences and potential negative impacts on medical innovation are listed and scored 0 to -5, based on the likelihood of these untoward effects happening. A final composite score (ranging from -10 to +10) is calculated and a recommendation is provided.

Currently, no analysis exists to evaluate rules solely with respect to their impact on the advancement of medical innovation, which is the purpose of the Medical Innovation Impact Index. MI3 alerts will be issued monthly.

About Fairleigh Dickinson University
Devoted to the preparation of world citizens through global education, Fairleigh Dickinson is New Jersey's largest private university and features more than 100 liberal arts and professional degree programs, two international campuses, dozens of partnerships with internationally renowned institutions and special programs and status within the United Nations.

Media Contact:
Dina Schipper
schipper(at)fdu(dot)edu     
201.692.7032

Read the full story at http://www.prweb.com/releases/2015/08/prweb12924128.htm.


'/>"/>
Source: PRWeb
Copyright©2015 Vocus, Inc.
All rights reserved

Related medicine news :

1. ADVOCATE Returns on Honorary Inc. 5000 List for Fourth Year
2. Heroes In Recovery to Host Fourth Annual 6k Run/Walk In Atlanta on July 25th
3. MD Now Urgent Care Opens its Fourth Miami-Dade County Facility in Cutler Bay
4. Luxury Linen Purveyor Peacock Alley Celebrates the Fourth of July
5. Stay safe this July Fourth with fireworks safety tips by an Akron General Emergency Medicine physician
6. Heroes In Recovery And The Oaks at La Paloma Host Fourth Annual Heroes in Recovery 6k Run/Walk In Memphis
7. Fourth Annual Nantucket Yoga Festival to be Held July 10-12 2015
8. Medical Solutions Announces Fourth Annual Nurses of Tomorrow Nurses Week Scholarship Contest
9. Array Health’s Senior Director of Marketing to Present at The Fourth Annual Direct-to-Consumer Health Care Marketing Summit
10. PureFormulas ranks among America’s leading web merchants for the fourth consecutive year
11. Southern New Hampshire University College of Online and Continuing Education Holds Tuition Rates for Fourth Consecutive Year
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/11/2020)... ... 11, 2020 , ... Help.org , a trusted online resource for individuals ... in Greenville, for 2020. The informational guide recognizes the top 8 rehab facilities ... recent studies , drug overdose is the leading cause of death among people ...
(Date:8/11/2020)... ... ... has seen a drastic change in how things are done on a daily basis due ... mask in public. Now, most states have made it compulsory as the need for authentic ... professionals in the U.S.A realized the shortage of PPE was inevitable. Dr. Rouhanian was no ...
(Date:8/9/2020)... ... , ... Dr. Angela Abraham has been appointed as the first-ever Diversity and ... leading the drive to foster a more equitable and bias-free NECO community. , In ... initiative led by Black Eyecare Perspective and dedicated to increasing Black presence in vision ...
(Date:8/7/2020)... ... 07, 2020 , ... Alexandria Dental Health & Smile Studio ... Mazhari, this well-respected practice offers advanced smile solutions to meet all of their ... exclusive group of dental practices with a large number of five-star ratings and ...
(Date:8/5/2020)... ... August 05, 2020 , ... ... (SEL) program, has been named to the inaugural list of Best Digital Tools ... , This recognition honors electronic resources that provide enhanced learning and curriculum development ...
Breaking Medicine News(10 mins):
(Date:8/12/2020)... ... 12, 2020 , ... Planet DDS is pleased to announce ... has acquitted 100% of Apteryx Imaging In.'s outstanding common and preferred shares for ... offer substantial value propositions to the dental industry, which this acquisition will allow ...
(Date:8/9/2020)... , ... August 09, 2020 , ... ... on sustainable results, today announced that Lydia C. Alexander, MD, has joined the ... medicine specialist, Dr. Alexander will play a vital role in expanding Enara Health’s ...
(Date:8/7/2020)... ... 07, 2020 , ... Glewed TV, a leading video-on-demand (VOD) ... content, today announced a partnership with award-winning director Charles Mattocks to air Eight ... The first reality TV series of its kind, Eight Days first aired on ...
Breaking Medicine Technology: