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, PD-1 Inhibitor Sponsors Discussing Real-World Study

Executive Summary

Agency would consider a site-agnostic indication for tumors with high mutation burden if results from the proposed pragmatic clinical practice study were positive.

You may also be interested in...



Immuno-Oncology’s Revolutionary Impact – On US FDA

Unprecedented wave of cancer immunotherapies is in some ways a mirror image of AIDS crisis as FDA explores new tools to accelerate drug development, including modeling techniques and statistical approaches to efficacy. It's an effort to encourage a regulatory revolution in response to a massive number of products in development as opposed to the AIDS-era effort to get products studied.

FDA Oncology Office Looks To Get Better INFORMED Through Big Data

Under the Information Exchange and Data Transformation initiative, existing clinical trial datasets will be standardized and integrated with real-world sources in a new data environment.

FDA Oncology Office Looks To Get Better INFORMED Through Big Data

Under the Information Exchange and Data Transformation initiative, existing clinical trial datasets will be standardized and integrated with real-world sources in a new data environment.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS057738

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