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By Catholic Online (NEWS CONSORTIUM)

4/22/2014 (2 years ago)

Catholic Online (www.catholic.org)

Program aims to streamline test and approval process

The U.S. Food and Drug Administration proposed a new program aimed at speeding up approvals for medical devices for patients who have no other treatment options available, on April 22.

The FDA's new program aims to get test products into the hands of patients who have no other treatment options.

The FDA's new program aims to get test products into the hands of patients who have no other treatment options.

Highlights

By Catholic Online (NEWS CONSORTIUM)

Catholic Online (www.catholic.org)

4/22/2014 (2 years ago)

Published in Technology

Keywords: Science, technology, US,


LOS ANGELES, CA (Catholic Online) - Called the Expedited Access Premarket Approval Application program, the program is focused on increasing interactions between the FDA and medical equipment companies, in response to criticisms by policymakers and patient groups, which claim that the FDA process for approving medical devices to those in need is too inefficient and slow, which harms the patients.

The program is aimed at reducing the time it takes to develop a product, and then get it into the hands of those who need it. It follows another new program by the FDA intended to speed up the development of certain cancer drugs at the clinical trial stage, said Morningstar analyst Debbie Wang.

Help technology and faith save lives.


"This is yet another aspect of how FDA is trying to work in a more coordinated fashion so they can reduce the number of false starts and situation of reinventing the wheel," Wang said. The program will "help put some priority on which therapies are going to affect the most patients with the greatest need."

If a device features some sort of technological breakthrough and has significant benefits over existing products, then it can be eligible for the program.

The program is designed as a response to dragging review times on numerous new product applications. Increases in fees paid by the industry to fund the FDA's work could allow the agency to put more manpower into the application process.

In September of 2013 the FDA issued a rule that required manufacturers of devices to put unique codes on their products to enable them to be regulated for safety reasons. The agency also issued final rules for using mobile medical apps, regulating only apps that turned smartphones into currently regulated devices, such as devices which determine if a patient is having a heart attack.

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Pope Francis: end world hunger through 'Prayer and Action'


Copyright 2016 - Distributed by THE CALIFORNIA NETWORK

Pope Francis Prayer Intentions for June 2016
Universal:
Human Solidarity: That the aged, marginalized, and those who have no one may find–even within the huge cities of the world–opportunities for encounter and solidarity.
Evangelization: Seminarians and Novices: That seminarians and men and women entering religious life may have mentors who live the joy of the Gospel and prepare them wisely for their mission.



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