federal_register: 2017-00374

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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
2017-00374 Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery." The guidance is intended to promote the safe use of nonprescription (also referred to as over-the- counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart. 2017-01-11 2017 1 https://www.federalregister.gov/documents/2017/01/11/2017-00374/recommended-statement-for-over-the-counter-aspirin-containing-drug-products-labeled-with https://www.govinfo.gov/content/pkg/FR-2017-01-11/pdf/2017-00374.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery." The guidance is...  

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