A factual overview — framed around governance and regulatory risk.

Therapy

Peptides

Peptide therapy has expanded rapidly in clinical settings, but the regulatory picture in the US is nuanced and evolving.

Key considerations

• FDA compounding categories and 503A/503B considerations
• Sourcing standards and supplier documentation
• Marketing language and off-label communication risk
• Consent frameworks reflecting current evidence

Therapy

Exosomes

The FDA's current position on exosome products for therapeutic use is restrictive. Practitioners need a clear-eyed view of the risk landscape.

Key considerations

• Current FDA statements and enforcement history
• Provenance, characterization, and manufacturer disclosures
• Marketing, testimonial, and outcome-claim exposure
• Documentation of medical rationale and informed consent

Therapy

Stem Cells

Cell-based therapies operate within the HCT/P framework and related FDA guidance. Governance and documentation are central to a defensible position.

Key considerations

• 361 vs 351 pathway and minimal manipulation analysis
• Homologous use assessment
• Clinic vs manufacturer role and responsibility
• Adverse event tracking and reporting standards