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 Pushing Generic Biologics Timetable In Election Year; "Structure" Expected Soon

This article was originally published in The Pink Sheet Daily

Executive Summary

Acting Commissioner Crawford's remarks on the feasibility of generic biologics reflect FDA's growing confidence that it can develop an approval pathway, after years of considering the issue too complex. He will testify on the issue during a Senate subcommittee hearing April 1.

You may also be interested in...



Follow-On Biologics Guidance Delayed, Agency Tells BIO

Broad scope and broad "interest" in the topic mean it will take FDA longer than expected to complete work on the highly anticipated guidance, Acting Deputy Commissioner Woodcock says. The guidance will include an "inventory" of different ways protein products have been regulated by the agency.

Follow-On Biologics Guidance Delayed, Agency Tells BIO

Broad scope and broad "interest" in the topic mean it will take FDA longer than expected to complete work on the highly anticipated guidance, Acting Deputy Commissioner Woodcock says. The guidance will include an "inventory" of different ways protein products have been regulated by the agency.

Generic Biologics Approval Process Is Focus Of Employers' Coalition

Coalition formed in 2003 to push Medicare Rx bill is preparing for a legislative effort next year on generic biologics. Group also wants $75 mil. budgeted for AHRQ drug comparison research.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059009

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