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Adverse Event Reporting News


Adverse Event Reporting News

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Product Description

Your subscription to Adverse Event Reporting News includes:

  • A biweekly publication in PDF format that you can distribute throughout your company or post on your intranet without penalty of copyright violation.
  • Discounted access to adverse event reports from FDA through our RECORD-RETRIEVE Service—we file FOIA requests for you!
  • Information on which firms—competitors, clients and suppliers—are getting cited in warning letters and 483s for complaint handling and AE reporting failures.
  • News from the EU on vigilance.
  • Insight on how FDA will regulate safety reporting and MDRs.
  • Information on which firms are trying to get copies of the reports you filed with FDA.
  • FDA MedWatch and labeling updates.

Get a FREE DVD of Bioresearch monitoring 483s and EIRs for sponsor/monitors, clinical investigators, IRBs, etc.  Regular price is $379 plus postage.

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