HBW Insight 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

Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters

This article was originally published in The Tan Sheet

Executive Summary

About 13% of the 156 warning letters FDA sent to dietary supplement firms from 2011 through June 2014 cited firms for failing to report serious adverse events or for not providing on product labels a domestic address or phone number at which to receive AERs. The citation total has climbed steadily from 2011.

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

CHPA board

Perrigo Consumer Healthcare Executive VP & General Manager John Hendrickson has been elected chair of the Consumer Healthcare Products Association by the group's Board of Directors, CHPA announces March 17 during its annual meeting in Aventura, Fla. The group announced Hendrickson as chair-elect in November (1"The Tan Sheet" Nov. 28, 2005, In Brief). Hendrickson succeeds Timothy Hayes of Bayer Healthcare, who will now serve as immediate past chair. In addition, the association, which was founded in 1881, is celebrating its 125th anniversary by unveiling a new, more "modern" logo, President Linda Suydam said...

J&J Consumer Sales Slip Even As Recalled Brands, Seasonal Items Reach Stores

J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.

Topics

Latest News
See All
UsernamePublicRestriction

Register

RS139706

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