Skip to content
Catholic Online Logo

By Catholic Online (NEWS CONSORTIUM)

4/22/2014 (3 months 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 (3 months 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.

---


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


2014 - Distributed by THE NEWS CONSORTIUM

Pope Francis Prayer Intentions for August 2014
Refugees:
That refugees, forced by violence to abandon their homes, may find a generous welcome and the protection of their rights.
Oceania: That Christians in Oceania may joyfully announce the faith to all the people of that region.



Comments


More Technology

A confident Ballmer leaves Microsoft 'completely' to run the Clippers Watch

Image of Steve Ballmer has left all positions of authority at Microsoft, leaving behind the tech giant to run the Los Angeles Clippers, for which Ballmer paid a record $2 billion.

By Catholic Online (NEWS CONSORTIUM)

Eight months after he ended his role as Microsoft CEO, Steve Ballmer resigned from Microsoft's board, a move that ends more than three decades of direct involvement in the world's largest software maker. LOS ANGELES, CA (Catholic Online) - The 58-year-old, who ... continue reading


Why did NASA turn the cameras off? Live feed from Space Station shows UFO, NASA cuts the feed Watch

Image of Is this evidence of a UFO? Or perhaps just venting gasses or debris from the ISS?

By Catholic Online (NEWS CONSORTIUM)

Fans of the International Space Station got an eyeful recently when an alleged UFO appeared on NASA's live feed from the station. Curiously, the feed was interrupted as soon as the object appeared fueling rumors that NASA is engaged in a cover-up. LOS ANGELES, CA ... continue reading


Have you been hacked? New report says millions of personal information has been stolen Watch

Image of Russian hackers recently gathered customer individuals from more than 420,000 websites.

By Catholic Online (NEWS CONSORTIUM)

Russian hackers gathered information from over 420,000 websites, both smaller sites and "household name" sites, in an attempt to gather passwords to send out spam. LOS ANGLES, CA (Catholic Online) - Hold Security, a Milwaukee-based firm, discovered the theft but ... continue reading


ROSETTA: After 10 long years - 'We're in orbit!' Watch

Image of Exciting new images, taken from just 80 miles away shows boulders, craters and steep cliffs.

By Catholic Online (NEWS CONSORTIUM)

All things come to those who wait. "After 10 years, five months and four days travelling towards our destination, looping around the sun five times, we are delighted to announce finally 'we are here,'" Jean-Jacques Dordain, ESA's Director General, said in a ... continue reading


Xiaomi overtakes Samsung as leading Smartphone maker Watch

Image of Xiaomi has evolved from a niche player in China to a major force in its home market.

By Catholic Online (NEWS CONSORTIUM)

How do you pronounce Xiaomi? Think of "show me," and then pronounce the first syllable as if it was in "shower." While Xiaomi in English translates as "little rice," there's nothing little about this Chinese Smartphone manufacturer - Xiaomi has knocked South ... continue reading


Next Mars rover will try to create oxygen on planet's surface Watch

Image of Being able to produce oxygen could help with that ambition, since transporting fuel is heavy and expensive. Other NASA spacecraft can already produce oxygen from CO2.

By Catholic Online (NEWS CONSORTIUM)

The next Martian rover that NASA sends to the red planet will attempt to make oxygen on the surface when it lands there in 2021. In addition, the rover will carry seven scientific projects, aimed at paving the way for future manned missions, seeking evidence of ... continue reading


Astronomers discover a 'magnifying glass' in space that acts like a time machine Watch

Image of Images which reveal the galaxies in question. They may look like pixels, however by examining light in fine detail with sensitive instruments astronomers can reveal a lot of basic knowledge about the objects.

By Catholic Online (NEWS CONSORTIUM)

Astronomers have discovered a virtual magnifying glass in space that allows them to look farther back in time than they normally can, to an age when the universe was young and contained less mysterious dark matter. LOS ANGELES, CA (Catholic Online) - Astronomers ... continue reading


Amazing sight beheld on Saturn's moon: More than 100 geysers spewing forth Watch

Image of NASA's Cassini spacecraft first spotted the geysers as plumes in 2005.

By Catholic Online (NEWS CONSORTIUM)

The universe has offered up many amazing sights over the past years, but the most recent one seems to take it all. At least 101 geysers have been discovered erupting on Saturn's frozen moon Enceladus. This find suggests that it may be possible for liquid water ... continue reading


Here are 12 amazing images of outer space. Number 6 is our favorite! Watch

Image of Nebulae are created when great stars explode, scattering their guts across space where they form new stars and solar systems.

By Catholic Online (NEWS CONSORTIUM)

There are wondrous sights in the heavens above! Space is packed with treasures beyond imagination. While we can see many things with just our eyes alone, instruments like the Hubble Space Telescope have given us some incredible close-ups packed with amazing detail. ... continue reading


Astronomers crack mystery of 'transformer' star Watch

Image of The mysterious star switches between two states of energy output, baffling scientists -- until now.

By Catholic Online (NEWS CONSORTIUM)

Astronomers have discovered a star that seems to vary and vanish in a surprising fashion. They mystery may now have been solved. LOS ANGELES, CA (Catholic Online) - Scientists observing a pulsar have been surprised to notice the star disappear and reappear in their ... continue reading


All Technology News

Newsletters

Newsletter Sign Up icon

Stay up to date with the latest news, information, and special offers

Daily Readings

Reading 1, Ezekiel 37:1-14
1 The hand of Yahweh was on me; he carried me away by ... Read More

Psalm, Psalms 107:2-3, 4-5, 6-7, 8-9
2 So let them say whom Yahweh redeemed, whom he ... Read More

Gospel, Matthew 22:34-40
34 But when the Pharisees heard that he had silenced ... Read More

Saint of the Day

Saint of the Day for August 22nd, 2014 Image

St. Andrew the Scot
August 22: Archdeacon and companion of St. Donatus. Andrew and his sister, ... Read More

Inform, Inspire & Ignite Logo

Find Catholic Online on Facebook and get updates right in your live feed.

Become a fan of Catholic Online on Facebook


Follow Catholic Online on Twitter and get News and Product updates.

Follow us on Twitter