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federal_register: 2011-10965

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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
2011-10965 Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products." This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug products packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, or spoons). FDA is issuing this guidance because of ongoing concerns about potentially serious accidental drug overdoses that can result from the use of dosage delivery devices with markings that are inconsistent or incompatible with the labeled dosage directions for orally ingested OTC liquid drug products. 2011-05-05 2011 5 https://www.federalregister.gov/documents/2011/05/05/2011-10965/guidance-for-industry-on-dosage-delivery-devices-for-orally-ingested-otc-liquid-drug-products https://www.govinfo.gov/content/pkg/FR-2011-05-05/pdf/2011-10965.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 "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products." This document is intended to provide guidance to firms that are...  

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