{"database": "openregs", "table": "dockets", "rows": [["FDA-2025-P-6315", "FDA", "Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling", "Nonrulemaking", "2026-05-12T14:26:15Z", "0b000064b90883fa"]], "columns": ["id", "agency_id", "title", "docket_type", "last_modified", "object_id"], "primary_keys": ["id"], "primary_key_values": ["FDA-2025-P-6315"], "units": {}, "query_ms": 0.5070139886811376, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}