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Extract every cited FDA regulatory-decision date from ONE SEC filing. Give an accession with its CIK, or a ticker or CIK to use the most recent matching 8-K or 6-K, and get all PDUFA, advisory committee, CRL, priority re...
Search FDA-regulated manufacturers in the public FDA establishment records by firm name and get ranked facility candidates, each with its FDA FEI number, location, product types, inspection count and latest inspection cl...
GMP compliance-risk dossier for an FDA-regulated manufacturer from public FDA records. Give an FDA FEI number or firm name and get a 0-100 compliance risk score, a low, medium, high or critical rating, the inspection-cla...
FDA inspection history for a manufacturer from public FDA records. Give an FDA FEI number or firm name and get the inspection classifications (Official, Voluntary or No Action Indicated) with the trend, plus the Form-483...
FDA enforcement history for a manufacturer from public FDA records. Give an FDA FEI number or firm name and get the compliance actions (warning letters, injunctions, seizures and consent decrees) plus the import refusals...