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March 2019 FDA Statement on Expanded Access

FDA Commissioner Dr. Scott Gottlieb joined CDER Director Dr. Janet Woodcock and CBER Director Dr. Peter Marks to make an important statement about Expanded Access (EA). In short, the message encourages “sponsors to offer EA in such circumstances, when continued access to a promising medicine at the completion of a clinical trial would be appropriate under the EA programs.”

Read the full statement.

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