FDA Adverse Event Reporting System to avoid medication errors

   2021-05-05       7        Business
Rating :
The FDA Adverse Event Reporting System (FAERS) is a publicly available database containing information on adverse events and medication error reports submitted to FDA.

What is the FDA Adverse Event Reporting System?

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event reporting regulations, is designed specifically to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. FAERS database adopted an informatic structure based on the guidance issued by ICH E2B or International Conference on Harmonisation. All approved drugs adverse event reports must be submitted by the manufacturer to FAERS electronically using the ICH E2B XML format which replicates Form FDA 3500A.

FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA to monitor various activities. FDA Adverse event reporting requirements include –

  • Looking out for new safety concerns that might be related to a marketed product
  • Evaluating a manufacturer’s compliance to reporting regulations
  • Responding to outside requests for information

An adverse event can be defined as any side effect or unexpected experience witnessed by humans with the use of a drug or other therapeutic biologic, irrespective of its relation to the use of the product. An adverse event could occur:

  • with use in professional practice
  • due to lack of expected effectiveness
  • from accidental or intentional overdose
  • from drug or prod"
  • "
"

Author Signature :


Jacktylor-compliancequest

100x100
Jack Tylor

ComplianceQuest Training Management System is a Software to train employees in a timely fashion and remain compliant with quality, compliance and safety management. Our training management system feat..


Random Articles

Add Hardwood Floors To Your Home To Give It A Classy Look!
Add Hardwood Floors To Your Home To Give It A..
   2018-12-18       135        Services
Best Event Management Company in Delhi
Best Event Management Company in Delhi..
   2020-02-09       67        Services
MARRIAGE REGISTRATION CERTIFICATE  IN DELHI
MARRIAGE REGISTRATION CERTIFICATE IN DELHI..
   2019-09-23       42        Services
Cooking Institute in Chandigarh | Cooking Classes in Chandigarh
Cooking Institute in Chandigarh | Cooking Cla..
   2020-09-19       35        Business
Packaging, Printing and Labeling Guide
Packaging, Printing and Labeling Guide..
   2019-10-01       60        Business
Employment visa services Dubai
Employment visa services Dubai..
   2019-06-03       94        Business
Getting a small business loan without security in Mumbai
Getting a small business loan without securit..
   2019-06-12       106        Finance
Top E- Commerce Magazine
Top E- Commerce Magazine..
   2019-11-23       52        News & Media
Aflas O-Rings | Buna O-Rings
Aflas O-Rings | Buna O-Rings..
   2019-08-31       87        Business
China Recycling Energy Corp Market Forecast to 2019
China Recycling Energy Corp Market Forecast t..
   2019-06-18       119        Business
The Best Side of traditional Belief
The Best Side of traditional Belief..
   2020-06-09       19        News & Media
5 Ways Professional Medical Billing Service can improve your Bottom Line
5 Ways Professional Medical Billing Service c..
   2019-11-30       43        Business
Land Rover Car Parts
Land Rover Car Parts..
   2019-08-23       88        Business
Why Food testing is important in India
Why Food testing is important in India..
   2020-07-16       25        Business
ABOUT US

Some quick example text to build on the card title and make up the bulk of the card's content Some quick example text to build on the card title and make up the bulk of the card's content Some quick example text to build on the card title and make up the bulk of the card's content.

TOP AUTHORS
Thomas Shaw
thomasshaw9688@gmail.com
Total Posts : 13094
zero promosi
zero1601@gmail.com
Total Posts : 1928