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 drug approval workshop

This article was originally published in The Tan Sheet

Executive Summary

A public workshop for businesses marketing unapproved OTC and prescription drugs will be hosted by FDA Jan. 9 in Rockville, Md., the agency announces in the Nov. 1 Federal Register. FDA will provide clarification and direction to companies on how to seek drug approval, and topics slated for the meeting include NDAs, ANDAs, OTC monographs, application processes, user fees and market exclusivity. Participants must register for the meeting by Nov. 15, which is also the deadline to propose discussion topics for the workshop. FDA says it is convening the meeting because many companies sought clarification following the June 2006 publication of the agency's Marketed Unapproved Drugs-Compliance Policy Guide (1"The Tan Sheet" June 12, 2006, p. 3)...
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS099920

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