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

UsernamePublicRestriction
UsernamePublicRestriction

FDA's OTC DRUG ADVERSE REACTION REPORTING SYSTEM PROPOSAL

This article was originally published in The Tan Sheet

Executive Summary

FDA's OTC DRUG ADVERSE REACTION REPORTING SYSTEM PROPOSAL projected for June release, according to the FDA regulatory agenda published in the April 25 Federal Register. The Nonprescription Drug Manufacturers Association has urged FDA to develop a system for requiring adverse drag reaction reports for OTCs based on the agency's current system for prescription drugs marketed without an approved NDA.

You may also be interested in...



People In Brief

Perrigo promotes in pricing, planning

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Topics

UsernamePublicRestriction

Register

ID1132115

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

Cancel