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:5/28/2016)... ... May 28, 2016 , ... In a part of the city where’s it’s easy to ... farm-to-table Kelowna restaurants is hoping to attract diners with a taste for real food. ... officially opened the doors to Cornerstone Grill, an urban casual restaurant focusing on dishes made ...
(Date:5/27/2016)... ... 27, 2016 , ... Two director-level employees of Horizon Blue Cross Blue Shield ... (TWIN) 2016 honorees. The award recognizes businesswomen who excel in their fields and ... of the MLTSS (Managed Long-Term Services and Supports) Program at Horizon NJ Health and ...
(Date:5/27/2016)... ... , ... With over 60 percent of acute stroke survivors being left unable ... aid in the rehabilitation process has steadily increased. Ekso Bionics had been working to ... to stroke. , Ekso Bionics has now received clearance from the U.S. Food and ...
(Date:5/27/2016)... ... May 27, 2016 , ... In ... the many who are unaware of the plight of aphasia. In collaboration with ... the “Stroke Awareness” campaign. , The link between stroke and aphasia is relatively ...
(Date:5/27/2016)... ... 2016 , ... Aimed at nurses and employees in the health care world, ... in the nursing and health care industry. It also provides insight to the developing ... , As the nursing industry is coming out of one of the biggest ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... , May 24, 2016 ... beide primären Endpunkte und demonstriert ... in ‚ausgezeichneter plus guter , ...    ,      (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a ... heute neue positive Daten von der MORA-Studie der ...
(Date:5/24/2016)... CHRISTCHURCH, New Zealand , May 24, 2016 ... scanning and informatics solutions for the healthcare sector, has been ... the New Zealand Hi-Tech Awards 2016. Dr ... a fantastic acknowledgement for our team.  It,s really good to ... the burden healthcare internationally. Our products are used in 35 ...
(Date:5/24/2016)... INDIANAPOLIS , May 24, 2016  Joe Marziani has joined VMS BioMarketing as ... chief executive officer, today. In his new role, Marziani will lead the company,s business ... care professionals to improve outcomes. Photo - http://photos.prnewswire.com/prnh/20160523/371089 ... ... ...
Breaking Medicine Technology: