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.

'/>"/>

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

Page: 1 2 3

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:10/30/2014)... Florida (PRWEB) October 30, 2014 Timothy, ... visit to Pompano Beach firefighters, showing that you are ... , Timothy met firefighters Tracey and Carl at ... Galuppi’s Restaurant and the Pompano Beach Chamber of Commerce. ... the fire truck, letting Timothy wear his real fireman’s ...
(Date:10/30/2014)... San Diego, Calif. (PRWEB) October 30, 2014 ... no longer mutually exclusive concepts in the medical-grade ... focusing on the development of uniquely potent topical ... Skin Health System ( http://www.RefinitySkinScience.com ) with patented ... highest available glycolic acid concentrations (50% and 70%) ...
(Date:10/30/2014)... Paramount Rx, a full-service prescription benefits manager ... help people save money through its innovative discount card ... drugs in the new health care system, the Paramount ... the relationship between consumers, businesses and the pharmacy industry. ... face today with medical costs is the rising price ...
(Date:10/30/2014)... Tara Haelle HealthDay ... -- More than 100 genes have been identified that ... report. And researchers say they are on their ... may contribute to the disorder. Autism spectrum disorders ... and social difficulties and repetitive behaviors. An estimated one ...
(Date:10/30/2014)... Dr. Joseph Furlin MD, a certified obstetrician and gynecologist, ... OB GYN in Melrose Park, IL and OB ... information about each of the care services and practice areas ... English and Spanish. The navigation of the website is ... provide Dr. Furlin’s patients with important information regarding his care ...
Breaking Medicine News(10 mins):Health News:4-year-old InstaKNOT CEO Honors Local Firefighters with Community Support 2Health News:4-year-old InstaKNOT CEO Honors Local Firefighters with Community Support 3Health News:4-year-old InstaKNOT CEO Honors Local Firefighters with Community Support 4Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 2Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 3Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 4Health News:Paramount Rx Discount Card Program Provides Valuable Resources in Midst of Current Health Care Reform 2Health News:Paramount Rx Discount Card Program Provides Valuable Resources in Midst of Current Health Care Reform 3Health News:Discovery of 100-Plus Genes Tied to Autism May Improve Treatments 2Health News:Discovery of 100-Plus Genes Tied to Autism May Improve Treatments 3Health News:Dr. Joseph Furlin Launches New Website with Information about Care Services 2
... myocardial perfusion imaging is common, and in many patients is ... a study in the November 17 issue of JAMA ... is being presented at the American Heart Association,s annual meeting. ... years, but along with the potential benefits has come an ...
... the gradual accumulation in the brain of amyloid-beta peptide which is ... protein known as APP, which is found in three forms. Most ... disease does not distinguish between the different forms of the ... Chemistry , show that amyloid beta peptide is actually created mainly ...
... Reporter , SUNDAY, Nov. 14 (HealthDay News) -- Moderate drinking ... than not drinking at all, according to a trio of ... in Chicago. Not only did male coronary bypass ... was also boosted by a cocktail now and then. ...
... , SUNDAY, Nov. 14 (HealthDay News) -- ... the brain alter how they view themselves and others, ... aptitude for introspection, researchers say. Georgetown University Medical ... of the five scattered brain regions that comprise what,s ...
... of adult smokers dramatically decreased during the past three ... more quitting and fewer picking up the habit, according ... Sessions 2010. The Minnesota Heart Survey, a population-based, serial ... between 3,000 and 6,000 participants in each of its ...
... do not get enough sleep have higher levels of ... researchers have found. Data from a recent study ... the American Heart Association Scientific Sessions in Chicago by ... School of Medicine. The results come from surveying ...
Cached Medicine News:Health News:Common for patients to undergo multiple cardiac imaging tests, with high cumulative radiation dose 2Health News:Common for patients to undergo multiple cardiac imaging tests, with high cumulative radiation dose 3Health News:'Magic number' 695 opens up new areas for Alzheimer's research 2Health News:A Little Alcohol May Help the Heart: Studies 2Health News:A Little Alcohol May Help the Heart: Studies 3Health News:Brain Organizes Itself for Introspection as Children Age: Study 2Health News:Smoking among some adults dropped dramatically in past three decades 2Health News:Smoking among some adults dropped dramatically in past three decades 3Health News:Smoking among some adults dropped dramatically in past three decades 4Health News:Smoking among some adults dropped dramatically in past three decades 5Health News:Smoking among some adults dropped dramatically in past three decades 6Health News:Poor sleep quality increases inflammation, community study finds 2Health News:Poor sleep quality increases inflammation, community study finds 3
(Date:10/30/2014)... LOS ANGELES , Oct. 30, 2014 /PRNewswire/ ... biopharmaceutical research and development company specializing in oncology, ... technology and its lead drug candidate, aldoxorubicin.  The ... A New Approach," will be given by ... the Sarcoma Oncology Center and principal investigator of ...
(Date:10/30/2014)... October 30, 2014 ... beim Aufbau von Kuhmilchverträglichkeit     Kuhmilchproteinallergie ... bei Säuglingen und Kleinkindern. Der bisher übliche ... Ernährung der Babys bzw. deren stillenden Mütter ... dass sich bei einer beträchtlichen Anzahl von ...
(Date:10/30/2014)... October 30, 2014 , Extensively ... cow milk   Cow milk protein allergy (CMPA) is the ... childhood. Until now, it has been managed by eliminating ... been shown that it is possible to help build ... number of children during the first year of life ...
Breaking Medicine Technology:CytRx Announces Oral Presentation at 2014 Chemotherapy Foundation Symposium 2CytRx Announces Oral Presentation at 2014 Chemotherapy Foundation Symposium 3CytRx Announces Oral Presentation at 2014 Chemotherapy Foundation Symposium 4Experten präsentieren neuste Forschungsergebnisse auf dem Allergy Day 2Experten präsentieren neuste Forschungsergebnisse auf dem Allergy Day 3Experts Present Latest Research at Allergy Day 2Experts Present Latest Research at Allergy Day 3
... Selective Kinase Inhibitor Phase 1 Trial in ... 9, 2008 EntreMed, Inc.,(Nasdaq: ENMD ... the treatment of cancer and inflammatory diseases, ... 1, dose-escalation study for its,selective kinase inhibitor, ...
... 2008 The Association,for Professionals in Infection Control ... MT, MPH, of Albany, NY, has been named,the ... Award.,APIC presents the annual award to an infection ... of Carole DeMille, a pioneer,in infection control. The ...
Cached Medicine Technology:EntreMed Achieves a Key Milestone Through Initiation of ENMD-2076 Clinical Program 2EntreMed Achieves a Key Milestone Through Initiation of ENMD-2076 Clinical Program 3EntreMed Achieves a Key Milestone Through Initiation of ENMD-2076 Clinical Program 4New York Infection Prevention Expert Named Recipient of Carole DeMille Award 2
... is a cost-effective synthetic bone filler ... Tricalcium Phosphate (TCP) and Hydroxyapatite (HAP), ... bone. BAB formulates the chemistry and ... regeneration. This formulation provides optimal osteo-conduction. ...
... quadripolar pacing wire design offers ... sensing in the atrium and ... wires in one lead design. ... and ventricle are color-coded for ...
... The TME 227 T is ... for temporary cardiac pacing and ... surgery. The TME 227 T ... the myocardium, which allows safe ...
For temporary cardiac pacing after open heart surgery. The zig-zag portion of the heartwire is embedded into the desired area of the myocardium (epicardially)....
Medicine Products: