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:10/13/2017)... ... 2017 , ... Lori R. Somekh, founder of the Law Office of ... elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office remain ... to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... ... ... Ellevate Network, the leading network for professional women, brought together some of ... their inaugural Summit in New York City in June. The event was livestreamed with ... 3 million. To watch the Mobilize Women video, click here . , ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) ... FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... Morris F. Collen, a pioneer in the field of medical informatics, this prestigious award ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... Pa. , Oct. 10, 2017   West ... in innovative solutions for injectable drug administration, today shared ... West,s ID Adapter for improving the intradermal administration of ... Fourth Skin Vaccination Summit in May 2017 by Dr. ... Lead, Polio Department, World Health Organization (WHO), and recently ...
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
(Date:10/4/2017)... , Oct. 4, 2017  According to the Centers for Disease Control ... of October . PhysicianOne Urgent Care is helping communities across ... NY , by offering no-cost* flu shots through the end of ... by certain health insurance regulations. ... best time to get a flu shot is by the end of ...
Breaking Medicine Technology: