The FDA maintains a public website of their letters sent to companies in the orthobiologic field. Every company on this slide has received some form of FDA inquiry. Some of the offenses are more egregious than others with patients blinded or given tainted product resulting in septicemia and life threatening illnesses.
Another Exosome Complication! Beware of misbranded biologic drugs that shouldn’t be used in Humans with no studies!
"Know Series" Exosome Tornados?
Question: Should a small Orthobiologic animal study immediately result in a mass produced biologic drug for humans?
* EXOSOMES * The Final FDA Word On Exosomes For Clinical Use In The USA. A well respected and thoughtful regenerative medicine doctor and educator recently took the time to do what I have been begging distributors and makers of allograft orthobiologics to do….ask the FDA about the regulatory requirements for their products! Thru the end of this year the FDA has a program called “TRIP” that is free and results in a prelim answer in 3 business days.