Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Follow-On Biologics Guidance Will Follow Public Workshop, Agency Tells Senate Committee

This article was originally published in The Pink Sheet Daily

Executive Summary

A public scientific workshop is planned for late summer; timing or content of a guidance cannot be predicted until after the meeting, Acting Commissioner Crawford tells Senate Judiciary Committee. Sen. Schumer expresses concern that progress towards "generic" biologics is "slowing."

You may also be interested in...



FDA Follow-On Biologics Public Meeting Slated For Early 2005

Projected timing of the meeting suggests that release of a draft guidance will not occur until at least a year after FDA’s original projected timeframe of spring 2004.

FDA Follow-On Biologics Public Meeting Slated For Early 2005

Projected timing of the meeting suggests that release of a draft guidance will not occur until at least a year after FDA’s original projected timeframe of spring 2004.

Barr's Generic Biologics Strategy Includes Outsourcing Manufacturing

The value of generic biologics will not come from manufacturing but rather from "navigating the regulatory and legal arena," CEO Downey says. Barr plans to detail its business plan by next June.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059779

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