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 Brand Name Rejections: Avoiding the "Train Wreck" Scenario

This article was originally published in RPM Report

Executive Summary

It's become all too common for sponsors: out-of-the-blue rejections of preferred brand names because a competitor's product sneaks through at the last minute. Now the agency is considering a policy change that would make the process more predictable.

You may also be interested in...



A Slow Takeoff for FDA's Brand Name Pilot Program

FDA's pilot program for testing and approving proposed brand names is slowly beginning to gain traction-despite initial concern from drug sponsors that the new process would lead to longer review times. For early adopters, it means a chance to collaborate with FDA on what will likely become the new regulatory standard. For everyone else, it may mean being a step behind.

A Slow Takeoff for FDA's Brand Name Pilot Program

FDA's pilot program for testing and approving proposed brand names is slowly beginning to gain traction-despite initial concern from drug sponsors that the new process would lead to longer review times. For early adopters, it means a chance to collaborate with FDA on what will likely become the new regulatory standard. For everyone else, it may mean being a step behind.

Branded for Failure? Industry Hesitant to Adopt FDA Brand Name Review Pilot

FDA wants industry to endorse a pilot program that would make sponsors responsible for testing proposed brand names for medication errors. Industry is concerned the process will make reviews less predictable. But sponsors should ask themselves this: what's less predictable than the current 40% rejection rate?

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM007466

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