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Keeping Track: CDER Approves Its First Two Novel Agents Of 2019

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate

CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.

Merck And The 'Strange Business' Of Antibiotics

Antibacterials have been part of Merck's mission for decades, despite the market challenges, and it's expecting two new approvals this year. Infectious disease VP Joan Butterton talks about tackling those challenges and incentives that may help the industry address antimicrobial resistance.

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