When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Al­though it’s ex­ceed­ing­ly rare for the FDA to re­scind a break­through des­ig­na­tion once it’s grant­ed, there has been a re­cent uptick …

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

‭ Regulatory Lead / Head of Regulatory‬

Autonomy Bio Inc.

San Francisco, CA 94107, USA