federal_register: 2016-31855
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-31855 | In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #242 entitled "In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products." The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This draft guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether or not the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling. | 2017-01-04 | 2017 | 1 | https://www.federalregister.gov/documents/2017/01/04/2016-31855/in-use-stability-studies-and-associated-labeling-statements-for-multiple-dose-injectable-animal-drug | https://www.govinfo.gov/content/pkg/FR-2017-01-04/pdf/2016-31855.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #242 entitled "In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products." The... |