federal_register: 2014-02555
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 |
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| 2014-02555 | Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Standardized Study Data; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Standardized Study Data." The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The draft guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This document supersedes the guidance entitled "Providing Regulatory Submissions in Electronic Format--Standardized Study Data" that was issued in February 2012. | 2014-02-06 | 2014 | 2 | https://www.federalregister.gov/documents/2014/02/06/2014-02555/revised-draft-guidance-for-industry-on-providing-regulatory-submissions-in-electronic | https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/2014-02555.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Standardized Study Data." The draft guidance announced in this notice is... |