Search openFDA drug labels (SPL) for a term.

Fetch Drugs@FDA application metadata for an NDA/BLA/ANDA number.

Resolve a brand or generic drug name to its NDA/BLA application number(s).

Bridges drug-name-only sources (registry inventories, product lists) to FDA regulatory metadata. Searches the brand and generic name fields directly rather than label prose, so another product merely mentioning this drug does not produce a false match.

EXPERIMENTAL. Sweep drug labels for registry / real-world-evidence signals.

Searches the label corpus for terms suggesting registry, natural-history or other real-world evidence, then aggregates hits by application number with snippets showing where each term matched.

This tool is unvalidated and has a known false-positive problem. It has no ground-truth oracle, and below the strongest hits the results are dominated by applications whose labels use "registry" in an unrelated sense. Its output is a candidate list for human review — not a finding, and not a count you should report.

Look up a CDRH device submission by its number.

Handles all four device pathways: 510(k) K-numbers ("K203571"), De Novo grants ("DEN160026" — stored in the 510(k) endpoint, not a separate one), PMA P-numbers ("P230044"), and HDE H-numbers. Supplement suffixes ("P230044/S001") are stripped before lookup.

Resolve a CDRH product code to its device class and medical specialty.

Validate a device number and derive class, specialty and category in one call.

Chains lookup_device_submission -> classify_device_product_code, which is the full three-hop resolution: number -> product_code -> classification.