Navigation Links
FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
Date:9/3/2009

WASHINGTON, Sept. 3 /PRNewswire-USNewswire/ -- Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration. A review of 1531 open postmarketing studies indicated that over 80 percent are proceeding according to the established timelines, have been submitted for FDA review, or have been determined by the FDA to have met their goals or are no longer needed.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

The study, done under a contract with Booz Allen Hamilton and supported by additional funds from Congress, examined the backlog of industry postmarketing studies for FDA-approved drugs and biologics. The review found that most companies meet their obligations in a timely manner.

The study also recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the FDA review, and the accuracy of the FDA's databases. The agency is evaluating the recommendations and already has made significant improvements based upon the study:

  • Establishment of a postmarketing study development coordinator and a tracking coordinator within each new drug division.
  • Development of new Manuals of Policies and Procedures (MAPP) for development of postmarketing studies and tracking the status of postmarketing studies.
  • Creation of a new postmarketing study database in the Document Archiving and Records Retention System (DARRTS) that includes increased capabilities for data capture, tracking, and generating reports related to postmarketing studies. This system was implemented the end of July 2009.

"New resources and directives from Congress have allowed us to complete this long-desired review," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The data indicate that makers of approved drugs and biologics are generally meeting their regulatory obligations and are on track with their studies. To date, we have not identified any previously unknown serious safety issues from the submitted final study reports."

Under the Food and Drug Administration Amendments Act of 2007, the FDA must undertake such a review annually. The review showed that the industry has been initiating most studies on time and submitting final reports for many studies, as required. Many of these reports are pending completion of a thorough FDA review. The FDA will continue to work with Booz Allen Hamilton to complete the agency's review of all submitted reports in a timely manner.

Manufacturers of drugs and biologics are also required to report to the FDA in a timely manner any serious safety issues that are identified from studies or other sources.

For more information

Booz Allen Hamilton report

Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments

Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... Dublin, CA (PRWEB) , ... June 27, 2016 ... ... Community College District , the only authorized OSHA Training Institute Education Center headquartered ... illness by protecting their workers from extreme heat at their worksites. Employers ...
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal ... Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Cut Pro X users can now reveal the media of their split screens ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... health professionals, announced today its affiliation with Tennessee Counseling Association. This ... the network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. ...
(Date:6/27/2016)... (PRWEB) , ... June 27, ... ... in the patient payment industry today announced its strategic partnership with Connance, ... system workflows. , The two companies’ proven, proprietary technology combine to provide ...
(Date:6/27/2016)... ... 2016 , ... A revolution is underway. Brooklyn-based company, ... for the millions of people who require these medical transport services annually. ... the use of technology. Now, SmartEMS has put forth an industry-changing app that ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... June 26, 2016 One of Australia,s ... the formation of a new biotechnology company, Noxopharm Limited [ABN 50 ... an IPO and to list on the ASX. Noxopharm ... ready to enter a Phase 1 clinical study later this year. ... address one of the biggest problems facing cancer patients - the ...
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/26/2016)...  VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) reported ... required to build a strong and stable market for ... on the OTC Markets-pink current trading platform. ... are seeing an anomaly in market trading activities that ... the Company, but shareholders and market players as well. ...
Breaking Medicine Technology: