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:10/13/2017)... ... October 13, 2017 , ... The American Board of ... its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his ... July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health ... technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing ... form that can be easily incorporated into liquid products, while reducing costs to end ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder ... of ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership ... rules. It also provides a forum to network with elder law attorneys nationwide,” said ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Many families ... However, many long-term care insurance companies have a waiver for care if the client ... elimination period, when the family pays for care, is often waived, so the benefits ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Lilly and Company (NYSE: LLY ) will ... 2017 on Tuesday, October 24, 2017. Lilly will also ... investment community and media to further detail the company,s ... at 9 a.m. Eastern time. Investors, media and the ... conference call through a link that will be posted ...
(Date:10/2/2017)... Denmark , Oct. 2, 2017 The Rebound ... in the struggle to reverse the tide of prescription drug ... for regulating their medicine intake and stepping down their dosage ... set to launch in December 2017; the first 100,000 people ... Learn more at http://www.rebound-solution.com/ ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
Breaking Medicine Technology: