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FDA Offers Criteria For Convening Advisory Committees In Draft Guidance

Executive Summary

FDA certainly has had its fair share of controversy in recent years, and now the agency is embracing controversy as a way to guide decisions about whether an issue is worthy of an advisory committee review

You may also be interested in...



Advisory Committee Vacancies Remain High As FDA Revs Up Search Efforts

With its recent hiring push drawing attention, FDA is quietly undertaking another recruitment effort - filling advisory committee roster vacancies

FDA Aims To Up Transparency By Making Panel Materials Public Sooner

FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a 1draft guidance released last week

NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance

FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications

Latest Headlines
See All
UsernamePublicRestriction

Register

PS049970

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