Changes to Adverse Event Reporting

The FDA recently issued a new draft guidance related to the electronic submission of postmarketing periodic adverse drug experience reports.

This is one of many important changes in adverse event reporting. Get the latest information in the updated book, Understanding FDA Drug and Biologic Adverse Event Regulations, 2005 Edition.

You'll find five new chapters, including --

• New guidance on submitting reports in electronic form to CDER and CBER
• Revision to the E2B(M) Q&A guidance for electronic transmission of individual case safety reports (ICSRs) to the FDA
• An addendum to E2C guidance for the preparation of periodic safety update reports (PSURs)
• Further guidance on the definitions and standards for postapproval expedited reporting
• A new guideline proposing a structure for a pharmacovigilance plan and principles of good practice for the design and conduct of observational studies

View the Table of Contents.

The key facts for reporting adverse events are compiled in this handy reference book, such as --

• Four core elements to include in a 15-day report
• When and how to submit follow-up, periodic and distribution reports
• Who's responsible for adverse event reporting
• How to handle 483s and EIRs
• Definitions of types of events and standards for expedited reporting
• How to handle electronic submissions of postmarketing expedited safety reports
• Five key factors to consider when implementing a MedDRA system
• How to maintain quality in recording adverse events using MedDRA
• A sample periodic safety update report and what to include in this report

Understanding FDA Drug and Biologic Adverse Event Regulations, 2005 Edition was published in February 2005. You pay $295 (plus $8 shipping and handling per book for orders shipped to North America, or $15 per book for orders shipped outside North America). Virginia residents please add 5 percent sales tax.

Please mention priority code 058CML when ordering.

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