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


MedWatch forms

This article was originally published in The Tan Sheet

Executive Summary

FDA decides against revising the 3500 (voluntary) and 3500A (mandatory) adverse event reporting forms, the agency announces in the Sept. 20 Federal Register. FDA received 21 comments in response to proposed changes announced in November. While comments on Form 3500 revisions were mainly favorable, comments on 3500A expressed concerns about financial burden on pharmaceutical and medical device industries in reprogramming computer systems. FDA says its decision "reflects both concerns about the financial burden that would be placed on FDA if the voluntary form underwent revision and the availability of other avenues by which use of the voluntary and mandatory forms can be optimized, namely appropriate revision of documents related to their completion." Updated instructions for completing 3500, including solicitation of dietary supplement information, were posted on the MedWatch home page in December, and a guidance for completing 3500A is being drafted

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