Human clinical
Regulated claims only. Intended use and status stated on every product.
Standards
Standards
A biologics group is only as good as the claims it refuses to make. This is the line we hold.
Claims
What we will and will not say.
What we say
- What a product is, what is in it, and what format it ships in.
- Its stated intended use and its regulatory status.
- Who may order it — physician, practice, or patient.
- The storage band it has to be held in.
What we do not say
- That any product cures, treats or prevents a disease unless a regulator has agreed it does.
- That a veterinary result carries over to humans, or the reverse.
- That a certification held by a supplier is a certification held by us.
- That published research on a different modality is evidence for ours.
Framework
How a product gets classified.
This is the framework the group works inside, not a claim about where any particular product lands. Classification is decided product by product, with counsel, and it is stated on the product.
- Q
Human cells or tissue?
- Q
Minimally manipulated and for homologous use?
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§361 HCT/P
Regulated as tissue. No premarket approval.
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§351 biologic
Requires a licence. BLA or IND pathway.
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Drug, device or supplement
Classified on its own pathway.
21 CFR 1271 · FD&C Act · PHS Act
Evidence
Each department answers to its own standard.
Human, veterinary and laboratory work are held to different evidence bars. Mixing them is the most common way a biologics company ends up making a claim it cannot support.
Veterinary
A separate evidence base and a separate regulator. Never cited as human evidence.
Laboratory
Assays report results. A result is not a diagnosis and is not presented as one.
Talk to the group
Tell us which department you need and we will route it. If you are ordering from one of the three named companies, their own sites are faster.
Talk to the group