FDA’s Rachel Sherman Addresses Right to Try, FDA Communication, and More

Last week FDA Principle Deputy Commissioner Rachel Sherman spoke at the BIO CEO & Investor Conference in New York about a variety of topics of interest to the gene and cell therapy communities, including Right to Try legislation and enhanced communication with the FDA during drug development. This article from Xconomy provides an overview of the issues Dr. Sherman addressed.

“Our primary concern—really our only concern—in this bill is that patients be protected," Sherman said of Right to Try proposals. "In the initial iterations of this bill, there was no stipulation about manufacturing. You could be making [a drug] in your bathtub at home and you could be selling it.”

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