Accelerated Approval
Definition
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.
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
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.
Biosimilar
A biological product shown to be highly similar to an approved reference biologic with no clinically meaningful differences. It is not a generic: biologics cannot be manufactured identically, so similarity has to be demonstrated rather than assumed.
Dietary Supplement
A US regulatory category for products intended to supplement the diet, which are not reviewed for safety or effectiveness before sale. Substances investigated as drugs are generally excluded from it, which is why peptides do not belong in that category.
Compounding
Preparing a customised medicine by combining or altering ingredients, done by a licensed pharmacy or an outsourcing facility. Compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before they are supplied.
Compounded Medication
A preparation made up by a licensed pharmacy for a specific patient's requirements. It sits under a different regulatory regime from a manufactured drug, with different expectations about testing, labelling and shelf life.