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FDA Commissioner Margaret A. Hamburg, MD, to Step Down

February 5, 2015—The US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, announced plans to step down from her post. In an open letter to her FDA colleagues posted on the agency’s website, Dr. Hamburg advised that that she will end her 6-year tenure at the end of March 2015. She also stated that the FDA’s Chief Scientist, Stephen Ostroff, MD, has agreed to serve as Acting Commissioner upon her resignation. Dr. Ostroff joined the agency in 2013.

Robert Califf, MD, Named FDA Deputy Commissioner

January 26, 2015—The US Food and Drug Administration (FDA) announced that FDA Commissioner Margaret A. Hamburg, MD, has appointed Robert Califf, MD, as FDA deputy commissioner for medical products and tobacco. He will join the FDA in late February.

FDA Seeks Comments on Proposed Guidelines for Device Design and Clinical Studies

August 15, 2011—The US Food and Drug Administration (FDA) announced that it has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

US Senate Confirms Dr. Robert M. Califf as FDA Commissioner

February 24, 2016—The US Senate voted to confirm President Obama’s nominee, Robert M. Califf, MD, to lead the Food and Drug Administration (FDA). Senators voted 89-4 on Dr. Califf's nomination.