Latest from the FDA

 
 
  • 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.
  • Montelukast's Underrecognized Adverse Drug Events Leukotriene inhibitors, montelukast in particular, have been linked to numerous reports of neuropsychiatric events. What should clinicians know?
  • FDA Updates Labels for Pregnant and Breastfeeding Women Find out how new FDA rules for prescription drugs will help you better determine risks for pregnant and breastfeeding women.
  • Targeting Drugs for Rare Diseases   Marshall Summar speaks with FDA director of the Office of Orphan Products Development, Gayatri Rao, about progress in diagnostics and therapeutics for rare diseases.
  • Responding to Ebola: The View From the FDA The FDA has ramped up its efforts to support product development, production, and availability as part of a massive international response to the ongoing Ebola outbreak.
  • FDA Approval 2.0: Dr. Kandzari Interviews Dr. Bill Maisel   Dr. Kandzari interviews Deputy Director of Science for CDRH, Dr. Bill Maisel, on strategies to expedite FDA approval while maintaining scientific rigor.