FDA Approval
Definition
A finding by the US Food and Drug Administration that a drug's benefits outweigh its risks for a specific labelled use. Approval is always for named indications and never for a substance in general, so a molecule can be approved for one use and investigational for every other.
What this means for research sourcing
Regulatory status varies by jurisdiction and applies to research supply, not human use. Volta sells to researchers only.
Related Terms in Regulatory
Indication
The condition and population a medicine is approved to be used in, as written in its labelling. It is the boundary that makes the difference between approved use and off-label use.
Investigational Drug
A substance under study that no regulator has approved for sale. In the United States it may be given to people only under an Investigational New Drug application. Most compounds supplied as research peptides are investigational or have never entered human study at all.
IND (Investigational New Drug)
The FDA application that allows an unapproved substance to be given to humans in a clinical trial. Most research peptides have no IND behind them, which is precisely why they cannot be marketed for human use.
Accelerated Approval
An FDA pathway permitting earlier approval for serious conditions with unmet need, based on a surrogate endpoint believed to predict clinical benefit. Confirmatory trials are still required and the agency can withdraw the approval if benefit is not confirmed.
Prescribing Information
The approved label for a medicine, carrying its indications, administration schedule, contraindications and warnings. It is the authoritative statement of what a drug is approved to do, and it is public.
DailyMed
The US National Library of Medicine's database of current FDA drug labelling, and the canonical place a prescribing information document is retrieved from rather than quoted secondhand.
Off-Label Use
Prescribing an approved drug outside the indication, population or schedule in its label. It is lawful medical practice in many jurisdictions, and it means the labelled evidence does not cover what is being done.
Orphan Drug
A designation for a drug aimed at a rare disease, under 200,000 patients in the United States, which carries development incentives and a period of market exclusivity. Designation is not approval and implies nothing about whether the drug works.