* 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. Chris Rogers sent a letter asking whether exosomes are a biologic drug or not in the FDA opinion. The FDA CLEARLY says that these products are drugs and to be regulated under section 351. Kimera, we have a problem….because last I checked your exosomes were registered under section 361. ANY doctor buying or using exosomes improperly registered is putting their patients and their careers at risk. Patients and their attorneys and the state medical boards and board certifying entities will now have proof that exosomes being sold and used in humans are unapproved drugs. To use this product, we must first be regulatory compliant!
Exosomes are biologic drugs and not cleared for sale OR use in the USA
Posted in: Amniotic Fluid/Umbilical Cord Blood/Whartons Jelly/Placenta, Exosomes!, Legal Issues With Regenerative Medicine (USA) | Posted on: 18 September, 2019