New plan by FDA will help critically sick get early access to care
By Catholic Online (NEWS CONSORTIUM)
4/22/2014 (2 years ago)
Catholic Online (www.catholic.org)
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.
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.
Copyright 2017 - Distributed by THE CALIFORNIA NETWORK
Pope Francis Prayer Intentions for FEBRUARY 2017
Comfort for the Afflicted. That all those who are afflicted, especially the poor, refugees, and marginalized, may find welcome and comfort in our communities.
The world waits with bated breath for a big announcement due from NASA on Wednesday. The announcement will take place at 1 PM Eastern time. ... continue reading
A Nevada state senator has proposed a bill that would protect citizens from being implanted with RFID chips. The bill, proposed by a ... continue reading
FOUR CLOSE CALLS in four weeks: Scientists wonder what's going on as four asteroids pass dangerously close to Earth Watch
Whoa, that's close! As the world worries about an asteroid due to pass Earth on February 25, a much closer shave is happening right now. ... continue reading
Astronomers think they have discovered a galaxy that is 99.9 percent dark matter. If true, the discovery is unprecedented. LOS ANGELES, CA ... continue reading
The world is closer to nuclear war than it has been in decades, and few people are paying attention. The Bulletin of Atomic Scientists have ... continue reading
by Catholic Online
- It is media, not Trump behind illusion of mass deportations
- Daily Readings for Wednesday, February 22, 2017
- Scientists predict Biblical flood for California HD Video
- St. Margaret of Cortona: Saint of the Day for Wednesday, February 22, ...
- Your Daily Inspirational Meme: God Also Has Things He Wants To Say To ...
- New pilgrimage route recreates Jesus' footsteps HD Video
- Wave of anti-Semitic threats end in vandalization horror - But ...
- St Joseph
- ten commandments
- Pope Francis
- saint agnes
- St Anthony
- 10 commandments
- mary magdalene
- Patron saints
- st bernadette
- pope francis
- St. John
- holy spirit
- morning prayer
- Saint Elizabeth
- St. Augustine
- Saint Anne
- st agnes
- saint monica
- saint catherine
- Saint Lucy
- saint clare
- saint rose
- Sts. Perpetua and Felicity HD
- Daily Reading for Thursday, February 23rd, 2017 HD
- California's floods predicted by scientists, but how? HD
- Pope Francis tells how to become a saint HD
Copyright 2017 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 2017 Catholic Online. Any unauthorized use, without prior written consent of Catholic Online is strictly forbidden and prohibited.