FDA BRIEF: Week of April 10, 2017
‘Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science
By: Suzanne Fitzpatrick, Ph.D., Senior Advisor for Toxicology, CFSAN
Creating human organ systems in miniature on micro-engineered chips
- Flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body
- First developed to evaluate the effectiveness of drugs
- Potentially useful technology to ensure food
Public-Private Collaboration
- FDA, NIH, DARPA
- Universities- Harvard, MIT
- Emulate founded by researchers at the Wyss Institute for Biologically Inspired Engineering, Harvard University
Autism: Beware of Potentially Dangerous Therapies and Products
There is no cure for autism
- Products or treatments claiming to “cure” autism do not work as claimed
- Same true of products claiming to “treat” autism or autism-related symptoms
- Some may carry significant health risks
- Examples: Chelation Therapies, Hyperbaric Oxygen Therapy, Detoxifying Clay Baths, various products, including raw camel milk and essential oils
FDA guidance on products with improper claims about intended use
- Be suspicious of products that claim to treat a wide range of diseases
- Personal testimonials are no substitute for scientific evidence
- Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
- So-called “miracle cures,” which claim scientific breakthroughs or contain secret ingredients, may be a hoax
America’s Got Talent – Regulatory Science Style
By: Stephen Ostroff, M.D., Acting FDA Commissioner
Students compete by presenting their proposed solutions to a current challenge in regulatory science
- University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI)
- University of Rochester’s Clinical and Translational Science Institute (CTSI)
The students identify the needs by consulting eight priority areas identified in FDA’s Strategic Plan for Regulatory Science
- Judged quality and novelty
- Proposed solution’s potential significance and feasibility
- Winning teams come to FDA to formally present ideas and have discussions with Agency scientists
List of Class I Exempt Devices
List of class I devices that are now exempt from premarket notification requirements
- In accordance with procedures established by the 21st Century Cures Act
- Will decrease regulatory burdens on the medical device industry
- Will eliminate private costs and expenditures required to comply with certain Federal regulation