FDA's Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles.
Implementation of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act of 2012 (Generic Drug User Fee Amendments. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments) successfully allowed the U.S. Food an...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 54; no. 4; pp. 758 - 764 |
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| Autores principales: | , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Jul2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=143830298&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 143830298 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Jul2020 vid: 54 iid: 4 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 143830298 143830298 143830298 10.1007/s43441-019-00016-2 143830298 ppf: 758 ppct: 6 formats: tig: atl: FDA's Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles. aug: au: Chazin, Howard Woo, Jason Han, Jing Grosser, Stella Luan, Jingyu affil: U.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, MD, USA sug: subj: Drugs, Generic Drug Approval United States Food and Drug Administration Program Implementation Human United States Collaboration Communication ab: Implementation of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act of 2012 (Generic Drug User Fee Amendments. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments) successfully allowed the U.S. Food and Drug Administration (FDA) to modernize review of Abbreviated New Drug Applications (ANDAs) with goal dates. The goal of this study was to assess the success of GDUFA I in decreasing ANDA time to approval and the number of review cycles across the five fiscal years of GDUFA I. Results of this study underscore FDA's continuous progress within its generic drug program and highlight the ongoing collaborative communication process between FDA and ANDA applicants that must continue for the timely approval of high-quality, safe, and effective generic drugs for the American public. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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