federal_register: 2011-4341

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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
2011-4341 Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to exercise enforcement discretion regarding dispensing requirements for Medication Guides that must be distributed with a drug or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 Second, the draft guidance addresses when a Medication Guide will be required as part of a REMS. The draft guidance is intended to answer questions that have arisen concerning these topics. 2011-02-28 2011 2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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This draft guidance...  

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