Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
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Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.
Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.
The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.