federal_register: E9-12743
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E9-12743 | Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing." This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing information. Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive. | 2009-06-01 | 2009 | 6 | https://www.federalregister.gov/documents/2009/06/01/E9-12743/guidance-for-industry-on-providing-regulatory-submissions-in-electronic-format-drug-establishment | https://www.govinfo.gov/content/pkg/FR-2009-06-01/pdf/E9-12743.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 "Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing." This guidance document is designed to... |