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 Science Board Will Look At “Future Plans” For “Critical Path” At Nov. 5 Meeting

This article was originally published in The Pink Sheet Daily

Executive Summary

The meeting is one of several by the agency to discuss the drug development initiative. The final report of FDA’s good manufacturing practices initiative will also be reviewed.

You may also be interested in...

FDA Seeks Input On GI Drug Bioequivalence Standards From Committee

FDA will also offer a revised bio-inequivalence proposal at an Oct. 20 Pharmaceutical Science Advisory Committee meeting. On Oct. 19, the committee will discuss FDA's Critical Path initiative, risk-based GMP progress and parametric interval testing.

CBER Embarks On “Critical Path”: Pre-Pre-IND Meeting Guidance Requested

FDA will consider defining the procedures for requesting "pre-pre-IND" meetings, the agency said at a public workshop on facilitating biologics development Oct. 7

HHS Medical Technology Innovation Report To Be Guided By Nov. 8 Hearing

A task force will hear input on what steps HHS can take to create or enhance coordination across agencies to stimulate the development of new drug, biological and medical device products. The task force’s report is expected to be released by year-end.

Related Content





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