ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)

  • Lakshmi Kanth Maddela
  • Insukh Oh

Abstract

A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has its own regulatory strategy to approve and allow generic drugs in to the market, which is named as Generic Drug Submission Review. FDA would like to slash the review time of generic drug application without compromising the quality and efficacy of proposed generic drugs for the intended use and to make them available to consumers in short time as possible. FDA has introduced Generic Drug User Fee program to supplement appropriate funding for resource management to ensure that consumers continue to receive the significant benefits offered by generic drugs. The purpose of this article is to present a concise overview about Generic Drug User Fee program and the recent advances in Abbreviated New Drug Application (ANDA) review process.

Keywords: FDA, FDASIA, ANDA, GDUFA, Generic Drug Submission.

Downloads

Download data is not yet available.

References

1. What are Generic Drugs - Office of Generic Drugs [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2009 May 12]. Available from:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm
2. Understanding Generic Drugs - Office of Generic Drugs [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2014 Oct 23]. Available from: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/default.htm
3. Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 - U.S. Food and Drug Administration [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 July 17] [cited 2012 Sept 09]. Available from:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm282513.htm
4. Ramesh T, Saravanan D, and Khullar P. Regulatory Perspective for Entering Global Pharma Markets. Pharma Times. Volume 43. No. 09; 2011 Sept.
5. Federal Food, Drug, and Cosmetic Act revised - U.S. Food and Drug Administration [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 July 09] [cited 2014 Feb 26]. Available from:
http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf
6. Generic Drug User Fee Amendments of 2012 - Guidance document [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2013 Sept 10] [cited 2014 Aug 22]. Available from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316671.pdf
7. Generic Drug User Fee-Backlog Fee Rate for Financial Year 2013 - Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 Oct 25] [cited 2012 Oct 25]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/ 2012-26257.pdf
8. Notice of Opportunity To Withdraw Abbreviated New Drug Applications To Avoid Backlog Fee Obligations - Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 Aug 27] [cited 2012 Aug 27]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2012-08-27/html/2012-20947.htm
9. Generic Drug User Fee Amendments of 2012 - U.S. Food and Drug Administration [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2015 Feb 12]. Available from:
http://www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm
10. Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 - Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 Oct 25] [cited 2012 Oct 25]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26256.pdf
11. Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2014 - Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2013 Aug 2] [cited 2013 Aug 2]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18625.pdf
12. Generic Drug User Fee - Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2015 - Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2014 Aug 1] [cited 2014 Aug 1]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2014-08-01/pdf/2014-18108.pdf
13. Initial Completeness Assessment for Type II API DMFs Under GDUFA - Guidance Document [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 Oct 02] [cited 2014 Aug 22]. Available from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321884.pdf
14. Abbreviated New Drug Application (ANDA) and Prior Approval Supplement (PAS) Fees – Question and Answers [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2014 July 31]. Available from:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319568.htm
15. Generic Drug Facilities, Sites and Organizations self Identification – Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2012 Oct 2] [cited 2012 Oct 2]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2012-10-02/pdf/2012-24326.pdf
16. Generic Drug Facilities, Sites and Organizations self Identification - Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2013 April 16] [cited 2013 April 16]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2013-04-16/pdf/2013-08806.pdf
17. Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013 – Federal Register [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2013 Jan 17] [cited 2013 Jan 17]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2013-01-17/pdf/2013-00851.pdf
18. Facility Fee - Question and Answers [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2014 July 31]. Available from:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319566.htm
19. User Fee Cover Sheets - U.S. Food and Drug Administration [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2014 Oct 24]. Available from:
http://www.fda.gov/ForIndustry/UserFees/default.htm
20. Generic Drug User Fee Cover Sheet and Payment Information - U.S. Food and Drug Administration [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2014 Aug 08]. Available from:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htm
21. Other Fee Related Questions - Question and Answers [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [date unknown] [cited 2013 Jun 21]. Available from:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319572.htm
22. FDSYS - Federal Digital System [Internet]. U.S. Government of Publishing Office, Washington, DC, USA [date unknown] [cited date unknown]. Available from:
http://www.gpo.gov/fdsys/search/home.action
23. CDER Small Business Webinar on Guidance for Industry: ANDA Submission – Refuse-to-receive Standards - U.S. Food and Drug Administration [Internet]. U.S. Food and Drug Administration, Silver Spring, USA [2013 Nov 18] [cited 2013 Nov 11]. Available from:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm374375.htm
Statistics
348 Views | 342 Downloads
How to Cite
Maddela, L. K., and I. Oh. “ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 1, Feb. 2018, pp. 41-61, doi:10.22270/ijdra.v3i1.157.