Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Safety Reporting For OTCs Should Allow Targeted Risk Management – CHPA

This article was originally published in The Tan Sheet

Executive Summary

FDA ought to consider targeted questionnaires for specific types of suspected adverse drug reactions (SADRs) rather than an "active query" approach when dealing with OTC products, CHPA says

You may also be interested in...



FDA’s Adverse Event Reporting Rule Would Generate “Noise,” PhRMA Says

FDA's proposed rule on suspected adverse events would generate excess reports without increasing the value of the surveillance, the Pharmaceutical Research & Manufacturers of America says

FDA’s Adverse Event Reporting Rule Would Generate “Noise,” PhRMA Says

FDA's proposed rule on suspected adverse events would generate excess reports without increasing the value of the surveillance, the Pharmaceutical Research & Manufacturers of America says

FDA’s Adverse Event Reporting Rule Would Generate “Noise,” PhRMA Says

FDA's proposed rule on suspected adverse events would generate excess reports without increasing the value of the surveillance, the Pharmaceutical Research & Manufacturers of America says

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS096070

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