FDA BRIEF: Week of July 3, 2017
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
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