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


FDA Schedules Biologics Specification Workshop

This article was originally published in The Pink Sheet Daily

Executive Summary

The workshop is part of a series of activities designed to recommend a comprehensive specification process from scratch rather than amend current practices. FDA has said release of a follow-on biologics guidance is on hold until after a forum on the subject is held.

You may also be interested in...

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

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."

Lupus Guidance Suggests Broad Use Of Health-Related Quality Of Life Endpoint

FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.

RiskMAP Guidance Includes Plans For A Website

FDA is planning to develop a Risk Minimization Action Plan website, an agency risk management guidance states





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