Navigation Links
Senate to Vote on Final FDA User Fee Bill As Early As Today
Date:6/25/2012

WASHINGTON, June 25, 2012 /PRNewswire-USNewswire/ -- The Senate is expected to vote as early as today on a final version of the FDA Safety and Innovation Act, which was passed by the House last week.  While the bill provides critical user fees to fund FDA oversight and makes some medical device safety improvements, it falls short of what is needed to protect patients, according to Consumers Union, the policy and advocacy division of Consumer Reports.    

"Americans are counting on the FDA to make sure that medical devices have been thoroughly reviewed so they don't harm the patients they are designed to help," said Lisa McGiffert, director of Consumers Union's Safe Patient Project (www.SafePatientProject.org).  "Unfortunately, too many dangerous medical devices have been allowed on the market because our current weak oversight system fails to protect patients.  This bill gives the FDA some new tools so it can better monitor medical devices once they are on the market, which could make it easier to notify patients when things go wrong and require more timely testing when safety problems are uncovered.  

But it does not give the FDA the stronger authority it needs to more thoroughly assess the safety of devices before they are allowed on the market."

While the bill does allow for easier reclassification of devices, which may allow the FDA to prevent some problematic devices from hitting the market, on balance it does more on the back end than the front end when it comes to improving oversight.  It doesn't provide the FDA with the authority it needs to thoroughly assess the safety of devices before they are allowed on the market.

Consumers Union had urged lawmakers to adopt a number of critical patient safety protections, such as
'/>"/>

SOURCE Consumers Union
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. CHPA Applauds Alabama Senates Passage of Anti-Meth Bill
2. Senate HELP Committee OKs Food and Drug Administration Safety And Innovation Act
3. Parent Project Muscular Dystrophy Endorses Senate Version of Prescription Drug User Fee Act After Patient Voice Strengthened
4. American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
5. NORD Calls Senate Bill Most Important Since Orphan Drug Act
6. Seventeen Banner Health facilities achieve final stage of electronic medical record adoption
7. Dr. Phillip Chan Named Finalist for Ernst & Young Entrepreneur of the Year® 2012 Award in New Jersey
8. DICOM Grid Selected as a Finalist for the 2012 Red Herring Top 100 Americas Award
9. Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
10. Perrigo Announces FDA Final Approval Of Tris Pharmas Dextromethorphan Polistirex Extended-Release Oral Suspension
11. Nearly 300 Medical Device, Healthcare Professionals Attend First National Conference on Value-driven Engineering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2014)... MONICA, Calif. , Aug. 28, 2014  In anticipation ... new infographic is being made available for the first time. ... San Diego offers a snapshot of ... industry. Highlighting everything from the latest employment statistics ... has made San Diego such a ...
(Date:8/28/2014)... LAKE CITY , Aug. 28, 2014 /PRNewswire-iReach/ -- ... 2000 by service academy graduates, has published a ... concentrated, three-day Leadership Excellence Course . In September ... Leadership Excellence Course to Albuquerque , ... Tucson . Photo - http://photos.prnewswire.com/prnh/20140828/140814 ...
(Date:8/28/2014)... LONDON , Aug. 28, 2014  A candidate ... The Gambia and Mali ... safety trials of potential vaccines aimed at preventing the disease that ... West Africa . Human trials of ... Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from ...
Breaking Medicine Technology:New Infographic Published - Overview of Medtech & Life Sciences Industry in San Diego 2Academy Leaders Publishes Case Study on Work with Global Pharmaceutical Company 2Academy Leaders Publishes Case Study on Work with Global Pharmaceutical Company 3Academy Leaders Publishes Case Study on Work with Global Pharmaceutical Company 4Academy Leaders Publishes Case Study on Work with Global Pharmaceutical Company 5Ebola vaccine trials fast-tracked by international consortium 2Ebola vaccine trials fast-tracked by international consortium 3Ebola vaccine trials fast-tracked by international consortium 4Ebola vaccine trials fast-tracked by international consortium 5Ebola vaccine trials fast-tracked by international consortium 6Ebola vaccine trials fast-tracked by international consortium 7
... ALBUQUERQUE, N.M., Jan. 26, 2011 ... Board: NMXC ), a developer of medical IT ... the healthcare community, announced today the implementation of a software ... its XR-EXpress telemedicine services to other systems. CEO ...
... SAN DIEGO, Jan. 26, 2011 The following statement ... LLP pursuant to an order of the United States ... TES DISTRICT COURTSOUTHERN DISTRICT OF NEW YORKHOWARD LEVINE, Individually ... Plaintiff, , vs. , ATRICURE, INC., et al., , ...
Cached Medicine Technology:Correction: New Mexico Software Unveils Additional Software Significantly Expanding Availability of Its Telemedicine Services 2Correction: New Mexico Software Unveils Additional Software Significantly Expanding Availability of Its Telemedicine Services 3Robbins Geller Rudman & Dowd LLP Announces Notice of Hearing to Determine Approval of Proposed Settlement of Class Action 2
(Date:8/29/2014)... August 29, 2014 As a chiropractic ... Fla., understands that there’s a direct connection between the ... hips and back. "Since conventional shoe inserts and orthotics ... solution of my own," he said. , Customizable to ... better support for the foot in order to help ...
(Date:8/29/2014)... (HealthDay News) -- The main strain of a ... and North Africa originated in sub-Saharan Africa, a ... methicillin-resistant Staphylococcus aureus (CA-MRSA) infections, which ... been hospitalized. These infections typically affect the skin ... through touching contaminated objects such as clothing or ...
(Date:8/29/2014)... For the fifth year in a row, ... observing September 26th as Mesothelioma Awareness Day, by attending ... , Members of the community who wish to ... will be providing t-shirts and signs to participating community ... have received attention from Al Roker and ...
(Date:8/29/2014)... PreDiabetes Centers , the country’s leading prediabetes treatment ... shoppers a 20% discount off orders of $100 or more ... living shop, beginning September 1. , Keeping your body ... the chilly fall season. , Autumn’s cooler, cozier weather often ... ditch the healthy salads and opt for creamy soups, hearty ...
(Date:8/29/2014)... Innovations Television, produced by DMG Productions, announced today ... focusing on health and elderly care, slated to air first ... Americans over 65 will nearly double by 2030, expanding from ... for a total of 72 million people. Though many older ... least one chronic condition and use healthcare services more often ...
Breaking Medicine News(10 mins):Health News: European MRSA Originated in Sub-Saharan Africa, Study Finds 2Health News:Organization to Raise Awareness of Mesothelioma on the Today Show 2Health News:PreDiabetes Centers Online Store Launches Fall Savings Event 2Health News:Innovations with Ed Begley, Jr., Seeking Content for Upcoming Series on Health and Elder Care 2
... Jonas in Los Angeles and,Become Part of "Team Jonas" ... To kick off Diabetes Awareness,Month, Bayer Diabetes Care announced ... meet teen pop sensation Nick Jonas of the Jonas,Brothers ... These Grand Prize winners will meet Nick Jonas in ...
... CLEMSON Clemson University researchers developing imaging agents to ... received $180,000 from the Susan G. Komen Breast Cancer ... cancer deaths in American women. , The new method ... resonance imaging) that may help researchers look at different ...
... University of Bristol brings stem cell therapies for heart ... bodies, ability to respond to an internal ,mayday, signal ... medicine. , Dr Nicolle Krnkel and colleagues at the ... DIY rescue and repair mechanisms when blood supply is ...
... kick off American,Diabetes Month this November, the American ... Detroit, along with Eli,Lilly and Company,s national educational ... Diabetes Update, an educational program for people affected ... Saturday, November 1, at the Greater,Grace Temple, 23500 ...
... from the Blue Cross Blue,Shield of Michigan Foundation ... elementary schools to help youngsters learn healthy lifestyle,habits ... University will use a BCBSM Foundation grant to ... and Redner --,part of Lincoln Consolidated Schools -- ...
... 30 Even though many hospitals have not,taken ... surgery,processes, those that do see significant improvements in ... case study recently,published by Kermit Randa of Surgical ... Group, Inc., outlines the benefits realized through the,implementation ...
Cached Medicine News:Health News:Bayer Diabetes Care Names 'Walk In Nick's Shoes' (W.I.N.S.) Sweepstakes Grand Prize Winners 2Health News:Bayer Diabetes Care Names 'Walk In Nick's Shoes' (W.I.N.S.) Sweepstakes Grand Prize Winners 3Health News:Susan G. Komen Breast Cancer Foundation awards grant for imaging-agent research 2Health News:Stem cell therapies for heart disease -- 1 step closer 2Health News:American Diabetes Association and Eli Lilly and Company Unite to Educate and Empower African-Americans with Diabetes 2Health News:American Diabetes Association and Eli Lilly and Company Unite to Educate and Empower African-Americans with Diabetes 3Health News:Blue Cross Blue Shield of Michigan Foundation Grant to Eastern Michigan University Will Help Ypsilanti Elementary Schoolchildren Lead Healthier Lives 2Health News:Blue Cross Blue Shield of Michigan Foundation Grant to Eastern Michigan University Will Help Ypsilanti Elementary Schoolchildren Lead Healthier Lives 3Health News:Healthcare Providers Improve Financial, Clinical and Operational Efficiencies Through IT 2
... SPECIFICATIONS Appearance/Form: White to buff-colored powder Activity: >=590g of ... (A&B): Passes tests Limit of Methanol: Specific Rotation ... pH (4%, H 2 O): 3.5 to 5.5 Loss ... C 1 : 25-50% C 2 + C ...
Gentamicin is a selection antibiotic used for selection of a Bac-to-Bac recombinant expression bacmid following transposition. Gentamicin is provided as a solution at a concentration of 50 mg/ml....
Gentamicin is an aminoglycosidic antibiotic that inhibits bacterial growth by inhibiting protein synthesis. Gentamicin is used for prevention and elimination of bacterial contaminants in cell culture...
1.0% Tryptone, 0.5% yeast extract, 0.5% Sodium Chloride, 0.6% agarose....
Medicine Products: