Publications

Adverse Event Reporting News

With FDA poised to introduce a new "safety reporting rule" for drugs and biologics and with ever increasing emphasis on minimizing medication errors, FDA inspectors are focusing more on complaint handling and corrective action. With this in mind, we created a news service devoted EXCLUSIVELY to adverse event reporting regulation.

Adverse Event Reporting News is the first and only publication that covers adverse events, including ADRs, MDRs, vaccines and dietary supplement, and vigilance reporting regulatory news from the European Union. It's your best solution for avoiding problems with FDA and foreign regulatory agencies.

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.

Order a full license today at $1689 and get a FREE copy of "The Guide to Vigilance and Adverse Event Reporting." Get all current FDA and EU guidance and regulations governing pharmacovigilance and medical device reporting — all in one handy guide. Regular price is $479, but is yours FREE with your order today!

 
Editorial Advisory Board:

Stephen A. Goldman, M.D.
Stephen A. Goldman Consulting Services, L.L.C.
Morris Plains, NJ

Elliot Brown, M.D.
Elliot Brown Consulting
London

Mariette Boerstoel-Streefland, M.D.
Mayne Pharma
Paramus, NJ

Click to order online

 

Call 703.779.8777 or EMAIL US with any questions.

Click here to visit FDADocuments.org to place your order