Over 100 Florida Auctions End Today - Bid Now
Over 1400 Total Lots Up For Auction at Six Locations - Over 120 New Jersey Auctions End Tomorrow 10/19 - Bid Now, MN 10/20, NY 10/22, NY 10/25, TX 10/28, CA 10/29

Obama signs FDA user fee renewal bill

by Brendon Nafziger, DOTmed News Associate Editor | July 10, 2012
The Food and Drug Administration user fee renewal bill is now the law of the land.

On Monday, President Barack Obama signed into law S.3187, or the FDA Safety and Innovation Act, which reauthorizes the FDA's powers to collect some $6.4 billion in user fees from medical device manufacturers and pharmaceutical companies to help offset the costs of application reviews and inspections.

The new law, which enjoyed hearty bipartisan support and sailed through both houses of Congress, increases the amount of money FDA can raise from companies and, for the first time, also applies to generic drug and biologics manufacturers.

New & Refurbished C-Arm Systems. Call 702.384.0085 Today!

Quest Imaging Solutions provides all major brands of surgical c-arms (new and refurbished) and carries a large inventory for purchase or rent. With over 20 years in the medical equipment business we can help you fulfill your equipment needs

The legislation also includes some tweaks pushed for by device companies. For instance, the FDA must measure the time it spends reaching a decision on a device submission by the total time used, rather than in "FDA days."

Significantly, too, it requires the FDA to release unique device identifier rules -- a new system for tracking medical devices in the supply chain -- by the end of the year. This point, however, is moot: the FDA released the rules, presumably not coincidentally, last week.
(16)
(2)
(3)

Ramon Cervantes

ITS ABOUT TIME THSE BILLION DOLLARS PROFIT COMPANIES PAY THE TAX

July 11, 2012 06:55

HE DAYS OF R%D DEVELOPMENT COSTS(THAT ARE OVERINFLATED FOR TAX BREAKS)SHOULD COME TO AN END. THE FDA NEEDS TO STAY ON THESE COMPANIES AND HUGE FINES FOR THE GREEDY PROFIT THEY MAKE

Log inor Register

to rate and post a comment

You Must Be Logged In To Post A Comment