The FDA’s Center for Biologics Evaluation and Research (CBER) regulates stem cell products. Stem cells normally require an investigational new drug application.
Physicians and healthcare companies such as pharmaceutical companies need to understand when remuneration violates the Anti-Kickback Statute. Some safe harbors may apply.
Nurse practices may consider using a managed service organization (MSO) to address corporate practice of medicine, anti-referral, and other compliance laws
Oncology practices may consider using a managed service organization (MSO) to address corporate practice of medicine, anti-referral, and other compliance laws