federal_register: 2016-28121
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-28121 | Nonprescription Sunscreen Drug Products-Format and Content of Data Submissions; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Nonprescription Sunscreen Drug Products--Format and Content of Data Submissions." This guidance addresses FDA's current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally recognized as safe and effective (GRASE), as provided under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). | 2016-11-23 | 2016 | 11 | https://www.federalregister.gov/documents/2016/11/23/2016-28121/nonprescription-sunscreen-drug-products-format-and-content-of-data-submissions-guidance-for-industry | https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-28121.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 guidance for industry entitled "Nonprescription Sunscreen Drug Products--Format and Content of Data Submissions." This guidance addresses FDA's current thinking on the... |