Latest from the FDA

 
 
  • FDA Updates Regulations on Mammography Proposed amendments to mammography regulations include increased reporting to patients and providers and greater transparency about mammography facilities.
  • Vaping and e-Cigarettes in Kids: An Unprecedented Epidemic   We are at the start of a rise in youth use of vaping products that is unprecedented in scope and exceeds growth rates previously seen with any other products. Clinicians have to be part of the response team.
  • Drug Safety Warnings and Updates: April-June 2018 Don't miss these important summaries of safety labeling changes and boxed warnings by the FDA for the second quarter of 2018.
  • Recommendations to Reduce Surgical Fires and Patient Injury Dr Lila Bahadori discusses the FDA's recent safety communication reviewing the factors that contribute to surgical fires and recommending practices to reduce them.
  • Drug Safety Warnings and Updates: January-March 2018 Don't miss these important summaries of safety labeling changes and boxed warnings by the FDA for the first quarter of 2018.
  • Drugs With a REMS: Benefit/Risk Counseling to Patients Do you know what to do when counseling a patient on a drug with a REMS designation? Learn more with new guidance from the FDA.
  • Drug Safety Warnings and Updates: October-December 2017 Don't miss these important summaries of safety labeling changes and boxed warnings by the FDA for the fourth quarter of 2017.
  • Safety in Pediatric Imaging: FDA Releases New Guidance When it comes to pediatric imaging, new guidance from the FDA offers specific recommendations for both practicing clinicians and equipment manufacturers.
  • Drug Safety Warnings and Updates: July-September 2017 Don't miss these important summaries of safety labeling changes and boxed warnings by the FDA for the third quarter of 2017.
  • 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.
  • 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.