Gottlieb's 2018 Generic Drug Approval Goal May Be In Doubt
Executive Summary
Thanks in large part to new elemental impurities requirements, ANDA approvals are behind the pace needed to beat 2017’s record.
You may also be interested in...
Is Bloom Gone From Rosy ANDA Approvals Figures?
US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market.
Is Bloom Gone From Rosy ANDA Approvals Figures?
US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market.
US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating
FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.