federal_register: 2011-29877

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-29877 Guidance for Industry on Medication Guide 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 guidance for industry entitled "Medication Guides-- Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the guidance addresses when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be provided with a drug or biological product that is dispensed to a health care 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 guidance addresses when a Medication Guide will be required as part of a REMS. The guidance is intended to answer questions that have arisen concerning these topics. 2011-11-18 2011 11 https://www.federalregister.gov/documents/2011/11/18/2011-29877/guidance-for-industry-on-medication-guide-distribution-requirements-and-inclusion-of-medication https://www.govinfo.gov/content/pkg/FR-2011-11-18/pdf/2011-29877.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Medication Guides-- Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This guidance addresses two...  

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