PDF Archive

Easily share your PDF documents with your contacts, on the Web and Social Networks.

Share a file Manage my documents Convert Recover PDF Search Help Contact



President Urges breaking down.pdf


Preview of PDF document president-urges-breaking-down.pdf

Page 1 2 3 4

Text preview


Document

Page 1 of 4

Related Articles: 4
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200 .
Printed by Mr. Norm Rabin, Maetrics LLC

President Urges Breaking Down Of
Drug, Device Distinctions, Regulatory
Barriers
By Ferdous Al-Faruque / Email the Author
Regulatory & Policy News / Word Count: 1154 / Article # 01160229017 /
Posted: February 25 2016 5:50 PM

FDA Funding Proposal Includes
Cross-Cutting Oncology Focus,
Disappoints Budget Advocates
“The Gray Sheet” Feb. 10, 2016
A Sharing Tool For Next-Gen
Sequencing: FDA Launches
precisionFDA
“The Gray Sheet” Dec. 17, 2015
FDA Reorganization Advocates
Seek Senate Boost For DiseaseOriented Structure
“The Gray Sheet” Nov. 30, 2015
Precision Medicine Plan 'Golden
Opportunity' For Device,
Diagnostic Firms
“The Gray Sheet” Sep. 18, 2015

Executive Summary
The White House held a summit on its Precision Medicine Initiative where
President Obama emphasized the need to break down outmoded regulations,
and suggested that the barriers between drug and device oversight need to
be loosened. Also at the meeting: FDA and NIH announced new competitions
and projects, including the launch of an effort to gather data from a million
Americans over the next few years.

President Barack Obama emphasized the need to break down regulatory barriers,
including regulatory distinctions between drugs and devices, to advance more
coordinated, personalized medicine during a Feb. 25 White House summit.
The gathering was held to discuss the next steps of the Precision Medicine Initiative
, which the president launched more than a year ago to bring different
stakeholders together to advance genomics-based treatments and other
technologies. (See "Precision Medicine Plan 'Golden Opportunity' For Device,
Diagnostic Firms" — "The Gray Sheet," Sep. 18, 2015.)
During the summit, the president emphasized that the goal of the initiative is to
figure out how to break down some of the structural and institutional barriers that
are preventing patients from getting treatment on a personalized level, and that
includes taking down outdated regulations while still protecting patients.

Topics Covered in
this Article
Click a keyword for related
articles.
Subjects
Clinical Development & Trials
Innovation
Personalized Medicine
Regulatory
Research & Development
Strategies
Industries
In Vitro Diagnostics
Biopharmaceuticals
Information Technology
Medical Devices
Laboratory Testing Services

He alluded to one particular issue that
appears to be gaining some traction in

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/president-urges-break... 2/26/2016