Latest from the FDA

 
 
  • 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.
  • The New Food Labels: Information Clinicians Can Use The FDA has proposed major updates to the Nutrition Facts label on packaged foods. What are the key changes that will help clinicians educate their patients about healthy food choices?
  • FDA's Rare Disease Program: A Rare Opportunity to Help Kids The first drug to come out of the FDA's rare pediatric disease priority review voucher program offers hope for patients with a rare progressive type of lysosomal storage disease.
  • Critical Intravenous Solution Shortages Demand during a busy influenza season is one factor underlying the current nationwide shortage of intravenous solutions. Medscape spoke with the FDA about this issue and its efforts to mitigate it.
  • Preventing Teen Tobacco Use: An Interview With the FDA The FDA has launched an ambitious campaign to prevent teens from initiating tobacco use. On the basis of extensive research, they have good reason to be optimistic that this one will work.
  • Acetaminophen, Opioids, and Safety Prescribers have been asked to avoid use of combination opioid products with more than 325 mg of acetaminophen. What are the data behind this decision?
  • Redefining 'Latex-Free' Current use of the term 'latex-free' in medical product labeling may give users with a natural rubber latex allergy a false sense of security. How will new draft guidance from the FDA help?
  • Removing Trans Fats From Foods: The FDA's View The FDA has recently proposed eliminating artificial trans fats from all foods. What are the implications?
  • Drugs and the Breastfeeding Mother: A New Clinical Report Out with the old 'alphabet letters' for classifying drugs in pregnancy and lactation, and in with a new system.
  • Breast Implants: The View From the FDA Medscape spoke with 2 experts from the FDA about safety issues with breast implants.
  • Choosing a Generic Antidepressant With one generic bupropion formulation recently withdrawn, how can clinicians best select from among the remaining options?
  • Flu and the FDA: An Interview With Margaret A. Hamburg, MD The FDA Commissioner discusses influenza prevention and management, including concerns about antiviral shortages and appropriate use in infants.
  • Telling the FDA: Why Contact Lens Adverse Events Matter The FDA requests that healthcare professionals report adverse events resulting from the use of contact lenses. Learn why it's important to report them and how to do so.
  • Decorative Contact Lenses: Truly Frightening Decorative contact lenses are widely used, especially at Halloween. Dr. Michelle Tarver discusses the risks posed by these often misused devices.
  • Contact Lenses: The Risks You Need to Know Although convenient, contact lenses can pose serious risks if not used and cared for properly. Dr. Bernard Lepri offers practical advice to reinforce to your contact lens-wearing patients.
  • Quinine and Leg Cramps: Not Worth the Risk The majority of quinine use in the US is off-label, despite significant adverse events. Why the continuing use?
  • The New Opioid REMS: The FDA View Why a new REMS for extended-release and long-acting opioid analgesics?
  • At-Home Rapid HIV Testing: An Interview With FDA Dr. Elliot Cowan of FDA's Center for Biologics Evaluation and Research discusses how to maximize benefit from the recently approved at-home rapid HIV testing kit, the OraQuick® In-Home HIV Test.