federal_register: 2011-10965
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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... |