Dr. Scott Bruder, MD, PhD., joins us for a “FRO ALERT” episode on the significance of the FDA consumer alert on regenerative medicine therapies. Dr. Bruder is the Founder and CEO of Bruder Consulting & Venture Group. He helps breaks down in orthobiologics what is legal, what’s not, what is compliant, what you can/can’t say and what you can/can’t use. Listen to this episode on this important information that is relevant for all our listeners, including medical sales, orthopedic surgeons and patients.
In this episode, Dr. Bruder breaks down the alert on June 3, 2021 from the FDA on “Important Patient and Consumer Information About Regenerative Medicine Therapies.” This latest alert on June 3rd makes physicians, companies and patients aware of which orthobiologics that are not approved. Other topics include:
-Clarification on terminology such as stem cells, regenerative medicine and orthobiologics
-What it means for FDA clearance vs. FDA approval
-Sage advice to surgeons, medical sales reps and patients seeking counsel on orthobiologics
Follow Dr. Scott Bruder on LinkedIn for more information.
For MD’s, capture quick reflections on each learning below & how it applies to your day-to-day to unlock a total of 1 AMA PRA Category 1 CMEs.
Podcast: Play in new window | Download (Duration: 34:31 — 31.7MB) | Embed
Subscribe: Apple Podcasts | Spotify | Email | TuneIn | RSS | More
Great show. Buyer beware….
So was the message to all the docs injecting patients with prp, “keep doing it” but don’t put it on your website? It is always great to have an intervention where the “natural history of the disease” is to get better (lateral epicondylitis, tendinitis, plantar fasciitis, low back pain). A sad day when physicians get in the same category as snake oil vendors.
Hi Dr. Clark,
Thank you for listening to the episode. The true message of the episode was awareness of this FDA consumer alert and helping to provide clarity for all listeners including physicians, medical device companies and patients. Our goal is to advance patient care by the sharing of information and hopefully helped some physicians with compliance with breaking down the info in this alert.