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

  • 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.
  • Are Healthcare Antiseptics Toxic to Staff and Patients? The FDA is embarking on an initiative to require data from manufacturers on the effectiveness and potential long-term toxicity of frequently used healthcare antiseptics.
  • Montelukast's Underrecognized Adverse Drug Events Leukotriene inhibitors, montelukast in particular, have been linked to numerous reports of neuropsychiatric events. What should clinicians know?