Checking a regulatory claim at its source
A search should identify the record supporting the claim.
Read country, product and scope before copying “approved.”
A search should identify the record supporting the claim.
Choose the appropriate register
For a US approval claim, FDA describes Drugs@FDA as an approved-product database. For Mexico, COFEPRIS offers its medicine-register search. Compare the name, presentation or form, holder and available indication, and retain the consulted record. No specific commercial product’s status was checked here.
Do not conflate presence and approval
The US label repository warns that it includes company-submitted information and that a label’s presence does not itself establish approval. A reading record should name the database supplying the result. If the match cannot be established, keep the claim pending confirmation.
Professional context / Contexto profesional
The Mexican search page was located through official sources; its direct interface could not be checked in this review.
Evidence / Evidencia
Documentary method, without a legal determination about a product.
Limitations / Limitaciones
Recheck records and validity before publication or a decision.