{"database": "openregs", "table": "federal_register", "rows": [["2011-4341", "Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).\" This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to exercise enforcement discretion regarding dispensing requirements for Medication Guides that must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient instead of being dispensed directly to the patient for self- administration or to the patient's caregiver for administration to the patient. Second, the draft guidance addresses when a Medication Guide will be required as part of a REMS. The draft guidance is intended to answer questions that have arisen concerning these topics.", "2011-02-28", 2011, 2, "https://www.federalregister.gov/documents/2011/02/28/2011-4341/draft-guidance-for-industry-on-medication-guides-distribution-requirements-and-inclusion-of", "https://www.govinfo.gov/content/pkg/FR-2011-02-28/pdf/2011-4341.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).\" This draft guidance...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2011-4341"], "units": {}, "query_ms": 0.7201437838375568, "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"}