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

FDA Estimates Dollar Costs For Adverse Event Labeling But Doubts Persist

This article was originally published in The Tan Sheet

Executive Summary

FDA's estimate of nearly $44 million for the dietary supplement industry to revise labels to comply with the adverse event reporting law may understate the actual burden by leaving out some key costs

You may also be interested in...



Final AER Guidance Requires Full Address, Recommends Prefatory Language

In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs

Final AER Guidance Requires Full Address, Recommends Prefatory Language

In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs

Final AER Guidance Requires Full Address, Recommends Prefatory Language

In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS102655

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