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

UsernamePublicRestriction

Pre-IND, End-Of-Phase II Meetings Can Decrease Development Time, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency data indicate taking advantage of the early meetings with FDA officials can dramatically decrease mean clinical development times, especially for rare disease applications.

You may also be interested in...



US FDA Begins Building Pharma Industry Activity Prediction Tool

Algorithms are intended to help predict incoming workload, which will be used to help set user fees.

FDA To Provide Expedited Approval Desktop Reference

Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.

Industry Wants A Breakthrough Therapy, Even Without All The Standards

A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.

Related Content

Topics

UsernamePublicRestriction

Register

PS073481

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