Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Pediatric Adverse Event Reporting Could Improve With Claims Database Analysis

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Pediatric Advisory Committee says the easiest short-term remedy for improving the quality of the agency’s adverse event reporting system would be claims database analysis, although the best method would be population-based active surveillance.
Advertisement

Related Content

Lotensin, Xenical, Brevibloc Need Continued Pediatric AE Monitoring – Committee
FDA Adding More Pediatric Data To Labeling
Lotensin, Xenical, Brevibloc Need Continued Pediatric AE Monitoring – Committee
FDA Adding More Pediatric Data To Labeling
FDA Adding More Pediatric Data To Labeling
Lotensin, Xenical, Brevibloc Need Continued Pediatric AE Monitoring – Committee
FDA Seeks To Enhance Reporting Of Pediatric Adverse Events
FDA Seeks To Enhance Reporting Of Pediatric Adverse Events

Topics

Advertisement
UsernamePublicRestriction

Register

PS061557

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel