federal_register: E9-2746

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

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 regulation_id_numbers
E9-2746 Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal Rule The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment. 2009-02-10 2009 2 https://www.federalregister.gov/documents/2009/02/10/E9-2746/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-postmarketing-reports https://www.govinfo.gov/content/pkg/FR-2009-02-10/pdf/E9-2746.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding...  

Links from other tables