federal_register: 2014-24796

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2014-24796 Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #227) entitled "Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections." The purpose of this document is to provide recommendations to sponsors submitting CMC data submissions. For review efficiency, the Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. This guidance describes the use of the two-phased technical section submission process. 2014-10-20 2014 10 https://www.federalregister.gov/documents/2014/10/20/2014-24796/two-phased-chemistry-manufacturing-and-controls-technical-sections-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2014-10-20/pdf/2014-24796.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #227) entitled "Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections." The purpose of this document is to provide...  

Links from other tables