Thursday, February 15, 2024


5:50. Can you explain the difference between "Expanded Use" and "Emergency Use."

6:00. Expanded access use pathway is was introduced in the late 1990s and it's a method for critically ill and terminally ill dying people who cannot participate in normal clinical trials to get access to drugs that are still in clinical trials so it was called expanded access use and in some subsections of it it has emergency use language and in the industry we all really called it emergency use authorization it's a right to try issue expanded access use has all the requirements of normal Pharmaceutical approval process for safety and efficacy the drug has to be investigational, legally it has to have investigational status IND has to be open for it investigational new drug exemption the clinical trials
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