Pink Sheet is part 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

Adverse Event Reports Rising, FDA Staffing Levels Not Keeping Pace

This article was originally published in The Pink Sheet Daily

Executive Summary

Adverse event reports per year have quadrupled over the last decade, and FDA expects the reports to retain their importance even as new technology helps with drug safety monitoring.

You may also be interested in...



Label Change Proposal From GPhA, PhRMA Makes FDA Responsible For Timing

“Expedited Agency Review” idea would require an FDA review of proposed safety-related labeling changes before they are made and end the CBE-0 system brand companies already use and generics could be required to adopt.

Adverse Event Reviews: FDA Needs To Boost ‘Accuracy And Efficiency’

Agency seeks academic institutions and commercial organizations with tools that can conduct automated analysis of case reports from FAERS data.

FDA’s Sentinel Likely To Outpace Traditional Post-Market Studies, But Will It Replace Them?

Pilot project for overactive bladder drug Mybretriq raises questions as to how Sentinel will affect sponsor’s risk-monitoring obligations.

Related Content

Topics

UsernamePublicRestriction

Register

PS077809

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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