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 Puts Dose Selection At Top Of Agenda For End-Of-Phase 2A Meetings

Executive Summary

Drug sponsors should use end-of-Phase 2A meetings for the in-depth discussions with FDA regarding dose estimation and selection that other pre-submission meetings do not allow for, according to a 1draft guidance

You may also be interested in...



EOP2A Guidance Allows That Resource Constraints Might Block Meetings

FDA's final guidance on end-of-Phase 2A meetings codifies into policy the more realistic expectations of what the agency can handle in terms of meeting requests.

EOP2A Guidance Allows That Resource Constraints Might Block Meetings

FDA's final guidance on end-of-Phase 2A meetings codifies into policy the more realistic expectations of what the agency can handle in terms of meeting requests.

Health Care and the 2008 Election: Revolution, Reform, or Return to Business as Usual?

As the presidential race heats up, health care executives say they have many reasons to be excited--and nervous. BCG reviews an industry-wide survey on the implications of the candidates' health care proposals for the pharma and device industries.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS050233

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