Navigation Links
FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
Date:6/15/2010

New website will contain safety reports on recently approved drugs, biologics

SILVER SPRING, Md., June 15 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA's website along with a brief discussion of the steps FDA is taking to address any identified safety issues.

Some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The new summaries provide a comprehensive look at safety data early in the product's post-approval life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System maintained by the FDA and the Center for Disease Control and Prevention; periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse even
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. DATATRAK Premieres Safety System at DIA
2. Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010
3. FDA Consumer Health Information - FDAs MedWatch Safety Alerts: May 2010
4. Abbotts Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves
5. New Data Reinforces Safety Profile of Abbotts Market-Leading XIENCE V(R) Drug Eluting Stent
6. ExpertRECALL Awards First Scholarships for Product-Safety Education
7. JCR and Hill-Rom Name Nurse Safety Scholar-in-Residence
8. New Data Demonstrate Safety, Efficacy of Stereotaxis for Patients with AFIB, VT and Congenital Defects
9. Improving Safety While Advancing the Pharmacy Technician Profession
10. FDA CONSUMER HEALTH INFORMATION - FDAs MedWatch Safety Alerts: April 2010
11. New Data Reinforces the Proven Safety and Effectiveness of the BIRMINGHAM HIP Resurfacing System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... , Aug. 28, 2015 ... the addition of the "Investigation Report on China,s ... Developed by Roche under the trade name of ... the world. In Feb.26, 2010, it was approved by ... available in China all come ...
(Date:8/28/2015)... 28, 2015  Today, in final recognition of the ... Health Week, 1-800 Contacts is sharing how to keep ... lens wearers who do not properly care for their ... infections. Most contact lens wearers understand ... clean lens case is sometimes overlooked.  When proper steps ...
(Date:8/28/2015)... Aug. 28, 2015 ... addition of the "Investigation Report on China,s ... offering. Developed by Novo Nordisk, insulin ... an important drug for the treatment of diabetes. ... fast- acting insulin analog, starts working fast and ...
Breaking Medicine Technology:Investigation Report on China's Bevacizumab Market 2015-2019 21-800 Contacts Shares Tips on How to Clean Lens Cases 2China Insulin Aspart Market Report 2010-2019 - Developed by Novo Nordisk 2
... Oct. 18, 2011 Aethlon Medical, Inc. (OTCBB:AEMD), ... address infectious disease and cancer, announced today that ... Linked Lectin Specific Assay (ELLSA™) from researchers that ... the  presence of exosomes in cell culture, ascites, ...
... LAKE FOREST, Ill., Oct. 18, 2011 Hospira, ... leading provider of injectable drugs and infusion technologies, today ... income from operations and adjusted* earnings per share are ... taken in response to a U.S. Food and Drug ...
Cached Medicine Technology:Aethlon Medical Announces Availability of its Exosome Detection Assay to the Research Community 2Aethlon Medical Announces Availability of its Exosome Detection Assay to the Research Community 3Hospira Announces Certain Preliminary Third-Quarter 2011 Results 2Hospira Announces Certain Preliminary Third-Quarter 2011 Results 3Hospira Announces Certain Preliminary Third-Quarter 2011 Results 4Hospira Announces Certain Preliminary Third-Quarter 2011 Results 5Hospira Announces Certain Preliminary Third-Quarter 2011 Results 6
(Date:8/29/2015)... (PRWEB) , ... August 29, 2015 , ... ... the company to freely market and sell Arterosil and Arterosil HP, and that ... Sciences, LLC (DHS) sued Vascular Health Sciences, LLC (VHS) in the United States ...
(Date:8/28/2015)... ... August 28, 2015 , ... Joining ... County Memorial Hospital recently transitioned management companies to partner with Wound Care Advantage ... their outpatient wound center. , Transitioning wound care management providers can be ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... Day at the Zoo to celebrate children helping children, a thank you to ... throughout West Ohio have contributed to the United Methodist initiative to end malaria ...
(Date:8/28/2015)... ... ... An article published August 19th by the LA Times documented ... open a pizzeria in Westchester. Mr. LaRocco was aware from opening prior pizza parlors ... current process, having already gone on for over a year, is taking much longer ...
(Date:8/28/2015)... ... August 28, 2015 , ... For Dallas, the time is nearing ... their subsidiary USPI Tenet Health. , The American Heart Association hosts their well-known Heart ... They believe that together, a difference can be made. Walkers can participate in the ...
Breaking Medicine News(10 mins):Health News:Decatur County Memorial Hospital Transitions Wound Center Management To Wound Care Advantage and the Luvo Operating System 2Health News:Decatur County Memorial Hospital Transitions Wound Center Management To Wound Care Advantage and the Luvo Operating System 3Health News:Decatur County Memorial Hospital Transitions Wound Center Management To Wound Care Advantage and the Luvo Operating System 4Health News:Saturday’s United Methodist Event at Columbus Zoo Celebrates Imagine No Malaria 2Health News:Saturday’s United Methodist Event at Columbus Zoo Celebrates Imagine No Malaria 3Health News:Article on Building Approval Process for LA Business Highlights the Need for a Bridge Between Businesses and City Officials, says Fire Protection Group Inc. 2Health News:North Central Surgical Center’s Subsidiary Participates in Walk 2
... A task force constituted by Haryana Agricultural University was recently ... in the state. // No evidence of bird flu infection ... of the state. ,'The members of the task ... mortality of two to five birds at a few poultry ...
... developed garments that could do much more than just cover ... vitamins, // underwear that can smell like vanilla and stockings ... garments that have been developed since the textile industry followed ... up with functional food. ,The garments have some ...
... district collectors in Orissa have been instructed to ban the ... against bird flu. // Orissa has over 59, 700 primary ... year. The ban would be retained for at least a ... has sent this instruction on Wednesday evening after a top ...
... is a sudden rise in the death rates due the people ... latest figures MRSA is now six times more likely to be ... (NHS) hospitals. A total of 1,168 people had MRSA recorded on ... contributory factor in 2004, a rise of 213 from 2003. ...
... of milking Medicare. Australian Medicare cards are being used by ... newspapers’, announcement today. These phony deals have cost a mammoth ... ,The agency has reported a case of a ... to use his Medicare card, to pocket the claim of ...
... not revealing vital data regarding the carcinogenic effects of ... to workers were largely under-reported. , ,A ... highlighted the incomplete data published with respect to hexavalent ... can be found in the Environmental Health journal. ...
Cached Medicine News:Health News:Bio-Functional Garments That Could Revolutionize Fashion Industry 2Health News:Bio-Functional Garments That Could Revolutionize Fashion Industry 3Health News:Rise in Deaths Rates Due To MRSA 2
Richardson Retractor...
A full, rounded look that adds greater dimension to the breast. Moderate base, with a higher profile than our Style 1600 implant....
... PTFE facial implant is an expanded ... augmentation or repair of the soft ... is available in sheets and shaped ... round facial implant strands are packaged ...
Chin Implants are used for cosmetic augmentation, repairing trauma related injuries and genetic deficiencies. They are inserted through an incision in the mouth below the incisor teeth or through an ...
Medicine Products: