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 Refines Guidance On Immunogenicity Testing

Executive Summary

FDA’s final guidance on the development of assays used in clinical trials to evaluate the immunogenicity of therapeutic proteins provides more detail on where immunogenicity information is to be placed in BLAs, and adds appendix on a multi-tiered approach to anti-drug antibody testing.

You may also be interested in...



Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.

Biologics Consortium Plans Collaborative Approach To Rapid Methods Validation

A plan to develop a “best practices” guide on validating rapid analytical methods for biopharmaceuticals is in the works.

US FDA Finds Negligible Cancer Risks In Metformin Products

The US FDA finds metformin meets NDMA impurity threshold and urges diabetics to continue taking it.

Topics

UsernamePublicRestriction

Register

PS124628

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