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Category: Pre-IND consultation Meeting

USFDA Publishes updated definitions FOR ‘Face-to-Face Meeting’

The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.

United States’ FDA issues guidance on Pre-IND meetings during COVID-19

In an effort to support sponsors responding to the public health emergency of COVID-19 pandemic, On May 2020, the FDA provided a guidance to assist sponsors in preparing pre-IND meeting requests for COVID-19 related drugs (human drugs and biological products).

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