“When Genetic Engineering Came Of Age”

Jim's Corner

October 29 was the 30th anniversary of the approval by the Food and Drug Administration (FDA) of human insulin synthesized in genetically engineered bacteria. In an article for Forbes, Henry Miller, the founding director of the FDA’s Office of Biotechnology, marked the anniversary and commented on today’s regulatory environment:

Regulators have adopted a highly risk-averse and even adversarial mindset, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by political forces outside the FDA.

 

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