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

Follow-On Proteins Draft Guidance Will Be Followed By Third Public Meeting

Executive Summary

FDA will hold a third public forum on follow-on proteins shortly after the release of a draft guidance on the topic, Acting Deputy Commissioner of Operations Janet Woodcock said Feb. 14

You may also be interested in...



FDA Generic Biologics Short-Term Plan Includes Immunogenicity Document

Immunogenicity and chemistry of follow-on biologics will be among the first issues FDA tackles in documents issued on the topic, Acting Commissioner Lester Crawford said at the Generic Pharmaceutical Association's annual meeting in Boca Raton, Fla

FDA Generic Biologics Short-Term Plan Includes Immunogenicity Document

Immunogenicity and chemistry of follow-on biologics will be among the first issues FDA tackles in documents issued on the topic, Acting Commissioner Lester Crawford said at the Generic Pharmaceutical Association's annual meeting in Boca Raton, Fla

Novartis Seeks To Be Generics “Powerhouse” With Eon, Hexal Acquisitions

Novartis expects the addition of Eon Labs and Hexal AG to its Sandoz division to create a generic drug "powerhouse" that will play a major role in the emerging "authorized" generics and follow-on biologics markets

Related Content

Topics

UsernamePublicRestriction

Register

PS045403

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