federal_register: 2013-21891
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-21891 | Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)." The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA also requires that generic drug facilities, sites, and organizations located around the world provide identification information annually to FDA. This guidance is intended to provide updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. | 2013-09-10 | 2013 | 9 | https://www.federalregister.gov/documents/2013/09/10/2013-21891/draft-guidance-for-industry-on-generic-drug-user-fee-amendments-of-2012-questions-and-answers | https://www.govinfo.gov/content/pkg/FR-2013-09-10/pdf/2013-21891.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)." The Generic Drug User Fee Amendments of 2012 (GDUFA) is... |