2023 Specialty Day Access Pass-Update on Regulatory Status: How to Stay out of Jail?

Update on Regulatory Status: How to Stay out of Jail?

Video Transcription

Video Summary

Dr. Scott discusses orthobiologics product development, safety, and regulatory oversight. The orthobiologic market is growing rapidly but includes many small companies, leading to potential bad practices. FDA regulations focus on product manufacturing, not medical practice, stressing minimal manipulation and homologous use. Stem cell therapies are not FDA-approved; claims about them are illegal. Physicians can legally use FDA-approved products based on clinical judgment but must avoid false advertising. Authorities like FDA, FTC, and DOJ are increasing enforcement, issuing warnings and subpoenas for non-compliance. Dr. Scott urges adherence to legal products, ethical marketing, and caution with unapproved therapies to avoid legal issues.

Asset Caption

Scott Bruder, M.D., Ph.D.

Keywords

orthobiologics

FDA regulations

stem cell therapies

medical product safety

regulatory enforcement