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


Adverse event reporting every six months "unwarranted" for OTCs -- NDMA.

This article was originally published in The Tan Sheet

Executive Summary

ADVERSE EVENT REPORTING EVERY SIX MONTHS IS "UNWARRANTED" FOR OTCs and other drugs with a long marketing history, the Non-prescription Drug Manufacturers Association stated in Jan. 25 comments to FDA. In response to a recent agency proposal revising the schedule for periodic adverse reaction reports for marketed drugs, NDMA said it supports the proposed reporting schedule for new chemical entities. "However, for drugs with a long marketing history (including OTC drugs)," NDMA said, "this proposed change is thought to be unwarranted and burdensome."

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





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