medwatch.JPG

  1. A way to send information to FDA
  2. A way to get safety information from FDA
  • Who, How, When What to report
  • High Quality Report Authoring : Tutorials, practices
  • Facilitated reporting: Online, Mail/Fax, Phone, Mobile

FDA Review and Actions from Reports : Signal Detection based on reports, Safety communications, Labeling changes

Resources :

www.fda.gov/MedWatch

www.fda.gov/ForPatient

www.fda.gov/ForConsumers

 

SLIDES

Published by Drug & Device Advisory Group


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