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

Lessons Learned: New FDA Guidance On Meetings With Sponsors Adds Depth

Executive Summary

FDA's new iteration of its guidance on meetings with sponsors reflects lessons learned during the surge in meeting requests the agency has had in the nine years since the original formal meetings final guidance was issued in February 2000

You may also be interested in...



REMS, ‘Breakthrough’ Meetings Get ‘Type B’ Tag In Revised FDA Guidance

In other modifications, FDA tells sponsors seeking Type A meetings – the most urgent category – that data packages must accompany the request.

BIO Chairman Sees "Science-Driven" Hamburg As Plus For Regulatory Climate

BIO Board Chairman Stephen Sherwin is looking forward to an improved regulatory environment at FDA for biopharmaceutical companies with the advent of Margaret Hamburg as agency commissioner

BIO Chairman Sees "Science-Driven" Hamburg As Plus For Regulatory Climate

BIO Board Chairman Stephen Sherwin is looking forward to an improved regulatory environment at FDA for biopharmaceutical companies with the advent of Margaret Hamburg as agency commissioner

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS051173

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