We ask you, humbly: don't scroll away.
Hi readers, it seems you use Catholic Online a lot; that's great! It's a little awkward to ask, but we need your help. If you have already donated, we sincerely thank you. We're not salespeople, but we depend on donations averaging $14.76 and fewer than 1% of readers give. If you donate just $5.00, the price of your coffee, Catholic Online School could keep thriving. Thank you.Help Now >
New plan by FDA will help critically sick get early access to care
FREE Catholic Classes
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.
We ask you, humbly: don't scroll away.
Hi readers, it seems you use Catholic Online a lot; that's great! It's a little awkward to ask, but we need your help. If you have already donated, we sincerely thank you. We're not salespeople, but we depend on donations averaging $14.76 and fewer than 1% of readers give. If you donate just $5.00, the price of your coffee, Catholic Online School could keep thriving. Thank you.Help Now >
Highlights
Catholic Online (https://www.catholic.org)
4/22/2014 (1 decade 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.
---
'Help Give every Student and Teacher FREE resources for a world-class Moral Catholic Education'
Copyright 2021 - Distributed by Catholic Online
Join the Movement
When you sign up below, you don't just join an email list - you're joining an entire movement for Free world class Catholic education.
-
Mysteries of the Rosary
-
St. Faustina Kowalska
-
Litany of the Blessed Virgin Mary
-
Saint of the Day for Wednesday, Oct 4th, 2023
-
Popular Saints
-
St. Francis of Assisi
-
Bible
-
Female / Women Saints
-
7 Morning Prayers you need to get your day started with God
-
Litany of the Blessed Virgin Mary
Ray Dalio Warns of Potential Civil War, Advises Moving Assets Abroad
-
Understanding Pentecost: A Celebration of the Holy Spirit in the Catholic Tradition
-
Did you know the Catholic Church has a birthday?
-
Catholic Bishops Call for Civil Dialogue Amid Church Polarization
-
Pope Francis Emphasizes Charity as the Pinnacle of Christian Love
Daily Catholic
- Daily Readings for Sunday, May 19, 2024
- St. Celestine: Saint of the Day for Sunday, May 19, 2024
- Prayer to St. Gabriel, for Others: Prayer of the Day for Friday, May 10, 2024
- Daily Readings for Saturday, May 18, 2024
- St. Pope John I: Saint of the Day for Saturday, May 18, 2024
- Prayer for Travelers: Prayer of the Day for Thursday, May 09, 2024
Copyright 2024 Catholic Online. All materials contained on this site, whether written, audible or visual are the exclusive property of Catholic Online and are protected under U.S. and International copyright laws, © Copyright 2024 Catholic Online. Any unauthorized use, without prior written consent of Catholic Online is strictly forbidden and prohibited.
Catholic Online is a Project of Your Catholic Voice Foundation, a Not-for-Profit Corporation. Your Catholic Voice Foundation has been granted a recognition of tax exemption under Section 501(c)(3) of the Internal Revenue Code. Federal Tax Identification Number: 81-0596847. Your gift is tax-deductible as allowed by law.