FDA Will Summarily Deny Petitions Submitted Solely To Block ANDA Approvals
This article was originally published in The Tan Sheet
Executive Summary
Blocking generic competition by using citizen petitions to delay abbreviated new drug application approvals just got harder, under an FDA draft guidance released Jan. 16
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In Brief
Guidance adds reasons for petition denial
In Brief
Guidance adds reasons for petition denial
In Brief
Guidance adds reasons for petition denial