FDA News: Biomarker for Acute Pancreatic Injury, Innovation Initiative and Cures Act, Nail Care Products – Drug and Device Digest

FDA BRIEF: Week of July 3, 2017

Spotlight on CDER Science

Lab Tests in Rodents Suggest Potential New Biomarker for Acute Pancreatic Injury

Biomarkers are measurable indicators that can signify presence/severity of disease 

  • FDA prioritizes identification of new, reliable and sensitive biomarkers

Acute pancreatic injury requires sensitive biomarkers

  • Numerous drugs, including those to treat type-2 diabetes, linked to pancreatic injury
  • Not evident in pre-approval, non-clinical safety and clinical trials with traditional pancreatic injury biomarkers, serum amylase and lipase
  • Thus more sensitive and specific biomarkers required to detect /monitor pancreatic injury potential of new drugs

Division of Applied Regulatory Science research suggest microRNAs (miRNAs) may be good biomarker candidates

  • Have a key role in the regulation of genes by repressing gene expression
  • Can increase rapidly after tissue injury
  • miR-216a, miR-217, miR-216b, miR-375, miR-148a able to detect pancreatic injury earlier and were more specific to pancreatic injury in rats and mice. These miRNAs also found in humans.
  • Additional data needed to determine utility in patients


Dr. Scott Gottlieb

Innovation Initiative: How FDA Plans to Help Consumers Capitalize on Advances in Science

FDA will soon unveil a comprehensive Innovation Initiative
  • Modern and efficient regulatory processes
  • Efficient and science-based regulatory principles
  • Remove regulatory barriers to beneficial new medical innovations
  • Help facilitate access to new innovations after FDA approval
  • Help maintain costs and hence, pricing, of new medical innovations

Detailed work plan to implement different aspects of Cures Act. Examples-

  • CDER: Modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms
  • CDRH: In silico regulatory models for product design and evaluation, digital library of models, family of “virtual patients” for device testing
  • CBER: Implementing the Regenerative Medicine Advanced Therapy designation,


How to Safely Use Nail Care Products

Cosmetic Nail Care Products: Ingredients and Warnings

  • Do not need FDA approval for marketing
  • But required to be safe when used as intended
  • Must include instructions or warnings needed for safe use
  • Consumers must read label prior to use
  •  FDA’s nail care products webpage

Nail Drying and Curing Lamps—and UV Exposure

  • Viewed as low risk when used as directed by the label
  • FDA has not received any reports of burns or skin cancer

Report Problems with Nail Care Products

  • FDA Consumer Complaint Coordinator
  • Medwatch


Image credit: FDA 

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