Pink Sheet is part of the Business Intelligence Division 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

Follow-On Biologics Guidance Delay Lauded By Senate Health Cmte. Staffer

Executive Summary

FDA should not issue a guidance on follow-on biologics until after Congress has established a regulatory pathway, Senate Health Committee Counsel Steve Irizarry said at an American Conference Institute meeting in New York June 25
Advertisement

Related Content

FDA Follow-On Biologics Public Meeting Slated For Early ’05
FDA Follow-On Biologics Public Meeting Slated For Early ’05
Follow-On Biologics Process May Allow Post-Approval Immunogenicity Tests
Follow-On Biologics Process May Allow Post-Approval Immunogenicity Tests
Follow-On Biologics Process May Allow Post-Approval Immunogenicity Tests
Follow-On Biologics Guidance Will Follow Public Workshop, FDA Tells Senate
GPhA “Generic” Biologics Proposal Includes Directive For FDA Advice
“Follow-On” Biologics Guidance Will Limit Use Of Data To “Public Domain”
“Follow-On” Biologics Guidance Will Limit Use Of Data To “Public Domain”

Topics

Advertisement
UsernamePublicRestriction

Register

PS044283

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