In Vivo 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
UsernamePublicRestriction

Investors Like “Breakthrough” Therapies, But Real Test Still To Come

Executive Summary

FDA confidence to devote time and resources for a breakthrough product resonates with investors and analysts, but the real program value in terms of product sales is yet to be seen. Sponsors also must be careful to manage investor expectations once the breakthrough designation is secured.

You may also be interested in...



Breakthrough In Two Pages: FDA Offers Preliminary Advice

Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.

PDUFA Negotiations: Early Communications, Breakthrough Still On Docket

FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.

PDUFA VI: Breakthrough Issues Among FDA Priorities

Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

WI965023

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