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This collection features FDA experts in original commentaries that are designed to improve communications between clinicians and this important federal agency. It covers a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices.

Latest from FDA

  • FDA Safety Labeling Changes: April-June 2017 Summaries of safety labeling changes and boxed warning highlights approved by the FDA for the second quarter of 2017 are presented.
  • Postmarket Drug Safety: The View From the FDA Two recent studies have raised potential concerns about the safety of newly approved drugs. What is the FDA's safety monitoring process, and are changes needed? Medscape spoke with FDA to find out.
  • Does Your Patient Need Both an Opioid and Benzodiazepine?   Dr Whyte warns us to use caution when prescribing opioids with benzodiazepines. Or better yet, avoid their combined use if possible.
  • Orphan Disease R & D Has a Home at FDA   Dr Rao talks to Dr Whyte about the FDA's orphan products grants program, their mission to promote the development of products, and the patient community's role.
  • FDA Issues Warning on Heater-Cooler Use During Surgery   The FDA's Dr Suzanne Schwartz explains these devices' risk of transmitting nontuberculous mycobacteria and how to mitigate it.
  • Abuse-Deterrent Opioids: What You Need to Know Abuse-deterrent drugs are the latest weapon against prescription opioid abuse and misuse in the United States.
  • The Brave New World of Biosimilars The FDA answers Medscape's questions about biosimilars: how they are defined, evaluated, approved, and regulated.
  • Navigating the New Clozapine REMS Medscape speaks with the FDA's Dr Mitchell Mathis about what clinicians can expect from the new clozapine REMS.
  • tPA and TNK Mix-ups: Clearing Up the Confusion   Patient deaths have been reported when healthcare providers confused tPA and TNK. Follow these suggestions to prevent any further mishaps.
  • Expanded Access: Recourse for Patients Out of Options   Patients who do not qualify for a clinical trial may still be able to receive an investigational drug. Learn about the easier-than-you-thought steps in the FDA's Expanded Access Program.