FDA Issues Draft Guidance Affecting Personalized Biologics

more+
less-

On July 14, the FDA issued a new draft guidance concerning in vitro companion diagnostic devices (“IVD companion diagnostic devices”). As explained in its press release, such IVD companion diagnostic devices are already in use to identify patients that are most likely to benefit from certain therapeutic products, such as some monoclonal antibodies.

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Dechert LLP | Attorney Advertising

Written by:

more+
less-

Dechert LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×
Loading...
×
×