Keeping Track: FDA Hands Out Complete Responses, Expedited Pathway Designations
The latest US drug development news and highlights from our Performance Tracker.
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Private Company Edition: BIO comments suggest definitions of personal data expand the scope of foreign investments in biotech companies that must be reviewed by the Committee on Foreign Investment in the United States (CFIUS). Also, NeuroRx’s $95m deal leads recent private financings.
AcelRx's sublingual opioid fills a need for narrow population, panelists conclude, despite US FDA's concerns about tablet size and committee's own worries about efficacy.
US FDA appears generally satisfied that AcelRx fulfilled initial safety concerns cited in October 2017 complete response letter.