Navigation Links
Drugs Approved Under Deadline More Likely to Run Into Trouble Later
Date:3/26/2008

Mandated approval times lead to fixes after medications have reached millions, study says

WEDNESDAY, March 26 (HealthDay News) -- New research shows that drugs that are approved quickly to meet mandated deadlines are more likely to run into trouble down the line, after they are in millions of Americans' medicine cabinets, than drugs that receive more deliberation before approval.

"It's not necessarily the case that these drugs should not have been approved, but it may have helped to have a black box warning in the first place rather than adding one three years later," said study author Daniel Carpenter, a professor of government at Harvard University. "It's not just the fact of approval. It's approval or regulatory processes assisting clinicians and patients with optimal use down the road. That's a big part of the approval process. It's not just saying yes and no, but saying with conditions and information that help us use drugs well."

The Prescription Drug User Fee Act (PDUFA), enacted in 1992, mandated that the U.S. Food and Drug Administration must act on 90 percent of all drug applications within 12 months of submission of the application or face funding cuts. That deadline was narrowed to 10 months in 1997.

"This study actually puts quantitative information around the question of whether the PDUFA user fee laws have resulted in a rush to approve things or to make decisions too quickly and many people, myself included, have worried about this," said Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation.

Many critics have also pointed out that the tighter deadlines were not accompanied by necessary increases in funding. "Every group that has looked at the FDA says it is underfunded," said Nissen, who has advocated for repealing PDUFA. "The right answer was to provide more resources so the FDA could evaluate applications more accurately
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4

Related medicine news :

1. New review suggests caution on drugs to raise good cholesterol
2. Can cancer drugs combine forces?
3. Study provides hope that some transplant patients could live free of antirejection drugs
4. Study provides hope that some transplant patients could live free of anti-rejection drugs
5. RA Drugs Linked to Slight Skin Cancer Risk
6. Report on patients access to cancer drugs uses flawed methods to reached flawed conclusions
7. Rock N Roll: Sex, Drugs and an Early Exit
8. Australian-led international study shows blood pressure drugs cut death rate in type 2 diabetes
9. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best
10. Are Bargaining Groups Hired by Independent Drugstores Causing Payment Delays to Pharmacies?
11. 2 drugs equally effective for heart patients undergoing angioplasty, Mayo study finds
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Drugs Approved Under Deadline More Likely to Run Into Trouble Later
(Date:6/3/2015)... evigilo, a world leader in delivering ... new branding by launching a new and enhanced content-centric ... identity: the logo depicting a sun-like image with a ... – To Know. To Act. In time. The color ... A global, borderless approach to alerting and delivering safety ...
(Date:6/2/2015)... (PRWEB) June 02, 2015 Allred Dental, a ... coupon for the months June-September, 2015 along with a $100 ... for limited time only. , “Sometimes wisdom teeth can be ... or jawbone. They can also only partially break through the ... and recovery is easier in young people, as they do ...
(Date:6/2/2015)... Pleasant Prairie, WI (PRWEB) June 03, 2015 ... suited for regulated industries such as government, finance and ... any organization that wants reliable access control to enhance ... smart card keyboard requires the secondary authentication of a ... In addition to the smart-chipset card reader, the ...
(Date:6/2/2015)... Los Angeles, CA (PRWEB) June 02, 2015 ... "100K Factory" system was released to public yesterday, ... around the Internet. HonestyFirstReviews.com's senior product reviewer Tiffany ... posting a detailed review of the course on ... of training courses available for Internet marketers looking ...
(Date:6/2/2015)... June 02, 2015 MEDIA ADVISORY, ... 571-319-9594 (cell) , Email: ewallace(at)mentalhealthamerica(dot)net , Breaking News: ... Mental Health Legislation at MHA Annual Conference Thursday ... Rep. Murphy to address the Mental Health America ... long-awaited updated version of the Helping Families in ...
Breaking Medicine News(10 mins):Health News:Keep calm! evigilos' "sun" will come out tomorrow – to know, to act, in time. 2Health News:$100 Off Coupon for Wisdom Teeth Extractions Offered at Allred Dental 2Health News:Introducing the New CHERRY JK-A0100EU Keyboard with Integrated Smart Card Reader for Access Control Security 2Health News:100K Factory - Review of Aidan Booth and Steve Clayton's New IM System Published 2Health News:Congressman Tim Murphy to Unveil Details of New Mental Health Legislation at MHA Annual Conference Thursday 2
... the use of the nucleoside polymerase inhibitor, R1626, to ... in the August issue of Hepatology , a ... of the American Association for the Study of Liver ... Interscience ( www.interscience.wiley.com ). , The first study ...
... world, scientists are attempting to recognize and treat schizophrenic ... this will improve the prognosis, which has often been ... International ( Dtsch Arztebl Int 2008; 105[30]: ... Psychotherapy at Cologne University describes the current state of ...
... Prevention Plan to Employers, DALLAS, July ... the leader in disease prevention,and Physicians Planning ... a,strategic alliance that will give PPG employee ... Medicine,s groundbreaking prevention program to,employers. Physicians Planning ...
... helps protect Verispan,s HIPAA-compliant, de-identified, patient-centric market research data used ... ... Reston, VA and Ottawa, ON (PRWEB) July 31, 2008 ... specializing in host intrusion defense, today announced that http://www.verispan.com/ ...
... ... PITTSBURGH, July 31 The Management Board of Bayer AG,announced ... Bayer,Corporation and the Senior Bayer Representative in North America,succeeding Dr. ... of service, effective October 1, 2008. Bayer Corporation is the ...
... In Recognition of World,Breastfeeding Week, Mary ... free online access to Breastfeeding Medicine, (http://www.liebertpub.com/bfm ... Breastfeeding,Medicine, a MEDLINE journal, the official publication ... international peer-reviewed medical journal,providing physicians with the ...
Cached Medicine News:Health News:New treatment therapy helps inhibit hepatitis C 2Health News:U.S. Preventive Medicine(R) Forms Strategic Alliance with Physicians Planning Group 2Health News:U.S. Preventive Medicine(R) Forms Strategic Alliance with Physicians Planning Group 3Health News:Verispan Calls on Third Brigade for Added Data Protection 2Health News:Verispan Calls on Third Brigade for Added Data Protection 3Health News:Photos: Bayer Names New U.S. CEO 2Health News:Photos: Bayer Names New U.S. CEO 3Health News:Photos: Bayer Names New U.S. CEO 4Health News:Mary Ann Liebert, Inc. Provides Complimentary Online Access to Breastfeeding Medicine for the Month of August 2
(Date:6/2/2015)... -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI ) announced ... Mark A. Sirgo , President and Chief Executive Officer of ... Jefferies 2015 Global Healthcare Conference Tuesday, June 2 2:30 ... City , NY The presentation will be ... For those who are not available to listen to the ...
(Date:6/2/2015)... 2015 Today the Council of State ... food companies, retailers, and human and animal health ... Stewardship. CSTE is committed to supporting changes that ... strains, preserve the efficacy of our existing antibiotics, ... CSTE continues to serve as a key ...
(Date:6/2/2015)... 2015  ErgoNurse, the leader in bedside safety management solutions, ... the United States , have formalized a ... and skilled nursing markets. ... Thousands of healthcare professionals ... advantage of the ErgoNurse products to stop unnecessarily utilizing their ...
Breaking Medicine Technology:BioDelivery Sciences to Present at the Jefferies 2015 Healthcare Conference - Schedule Change 2BioDelivery Sciences to Present at the Jefferies 2015 Healthcare Conference - Schedule Change 3ErgoNurse and Briggs Healthcare Positioned to Completely Eliminate the Unnecessary Cost of Healthcare-Related Back Injuries 2
... 2010 Telik, Inc. (Nasdaq: TELK ) ... drugs to treat cancer, announced that it has been ... Therapeutic Discovery Project (QTDP).  The grants are intended to ... including the company,s most advanced investigational drug candidate, TELINTRA®, ...
... Nov. 2, 2010 OncoMed Pharmaceuticals, Inc., a ... cells, announced today that it has been awarded ... under the U.S. Government,s Qualifying Therapeutic Discovery Project ... by the company received an award.  The funds ...
Cached Medicine Technology:Telik Awarded $1.2 Million in Grants for Qualifying Therapeutic Development Projects 2OncoMed Pharmaceuticals Awarded Five Therapeutic Discovery Project Grants Totaling $1.2 Million 2OncoMed Pharmaceuticals Awarded Five Therapeutic Discovery Project Grants Totaling $1.2 Million 3
The PC2200h contains two shelves and will hold two PF96hi agitators. It can store 192 random bags (64 apheresis bags)....
The PC3200i has three shelves and will hold three PF96i agitators. Total capacity is 288 random bags (96 apheresis bags)....
... rotators and agitators for continual ... set at 22C (71F) or ... (59F to 104F). Uniformity is ... bottom. Recorder is standard on ...
... incubators hold rotators and agitators ... can be set at 22C ... to 40C (59F to 104F). ... top to bottom. Recorder is ...
Medicine Products: