5 Topic Commentaries

New to Market

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  Patrizia Cavazzoni, MD

  Director, Center for Drug Evaluation and Research (CDER)

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  U.S. Food and Drug Administration

  “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,”

  [Source]
• 

  Peter Marks, MD, PhD

  Director, Center for Biologics Evaluation and Research (CBER)

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  U.S. Food and Drug Administration

  “Today’s approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection,”

  [Source]
• 

  Sally Seymour, MD

  Director, Division of Pulmonology, Allergy, and Critical Care, CDER

  •

  U.S. Food and Drug Administration

  “Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,”

  [Source]
• 

  John Sharretts, MD

  Director, Division of Diabetes, Lipid Disorders, and Obesity, CDER

  •

  U.S. Food and Drug Administration

  “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

  [Source]
• 

  Robert M. Califf, MD

  Commissioner, U.S. Food and Drug Administration

  •

  U.S. Food and Drug Administration

  “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose.”

  [Source]