Interview Questions on ANDA filing

  • Rajkumar Gupta

Abstract

This guidance document provides prominent facts on ANDA filings in FAQ format. It covers aspects like drafting, submission, review, approval of ANDA in question answer format. It is an excellent database for those seeking appointment in large pharmaceutical companies.

Keywords: Drug Master File (DMF), ANDA, NDA, FDA, CDER, OGD

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References

1. ANDA Forms and Submission Requirements [Internet]. US FDA; 2019 [cited 2021 Jan 11]. Available from: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/abbreviated-new-drug-application-anda-forms-and-submission-requirements
2. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) [Internet]. U.S FDA; 2018 May 17 [cited 2021 Jan 10]. Available from: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.htm
3. Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms [Internet]. US FDA; 2012 Apr [cited 2021 Jan 13]. Available from: https://www.fda.gov/media/83664/download
4. Determining Whether to Submit an ANDA or a 505(b)(2) Application [Internet]. US FDA; 2019 [cited 2021 Jan 12]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determining-whether-submit-anda-or-505b2-application
5. Question-Based Review for CMC Evaluations of ANDAs [Internet]. US FDA; 2019 Nov 11 [cited 2021 Jan 19]. Available from: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/question-based-review-cmc-evaluations-andas
6. Generic Drug User Fee Amendments [Internet]. US FDA; 2021 Feb 10 [cited 2021 Jan 19]. Available from: https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments
7. Abbreviated New Drug Application (ANDA) [Internet]. US FDA; 2019 May 22 [cited 2021 Jan 19]. Available from: https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda
8. Abbreviated New Drug Application (ANDA) and Prior Approval Supplement (PAS) Fees [Internet]. US FDA; 2017 Jan 19 [cited 2021 Jan 11]. Available from: https://www.fda.gov/industry/generic-drug-user-fee-amendments/abbreviated-new-drug-application-anda-and-prior-approval-supplement-pas-fees
9. ANDA Submissions -Content and Format Guidance for Industry [Internet]. US FDA; 2019 Jun [cited 2021 Jan 19]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/anda-submissions-content-and-format-abbreviated-new-drug-applications
10. Field Alert Reports [Internet]. US FDA; 2018 Jul [cited 2021 Jan 13]. Available from: https://www.fda.gov/drugs/surveillance/field-alert-reports
11. Pre-ANDA Program & Complex Generic Products [Internet]. US FDA; 2017 Oct 27 [cited 2021 Jan 13]. Available from: https://www.fda.gov/industry/generic-drug-user-fee-amendments/pre-anda-program-complex-generic-products
12. ANDA Submissions - Refuse-to-Receive Standards Guidance for Industry [Internet]. US FDA; 2016 Dec [cited 2021 Jan 12]. Available from: https://www.fda.gov/media/86660/download
13. ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers [Internet]. US FDA; 2014 May [cited 2021 Jan 12]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-stability-testing-drug-substances-and-products-questions-and-answers
14. ANDAs: Impurities in Drug Substances [Internet]. US FDA; 2020 Apr 04 [cited 2021 Jan 12]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-impurities-drug-substances
15. Good ANDA Submission Practices Guidance for Industry [Internet]. US FDA; 2018 Jan [cited 2021 Jan 12]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry
16. Shah S, Badjatya JK. Preliminary requirement for filing application in US. Int J Drug Reg Affairs [Internet]. 2018 Dec 20 [cited 2021 Jun 15];6(4):1-8. Available from: http://ijdra.com/index.php/journal/article/view/276
17. M SK, Katamreddy JD, P JR. A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines. Int J Drug Reg Affairs [Internet]. 2018 Sep 15 [cited 2021 Jun 15];6(3):5-12. Available from: http://ijdra.com/index.php/journal/article/view/260
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How to Cite
Gupta, R. “Interview Questions on ANDA Filing”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 20-25, doi:10.22270/ijdra.v9i2.464.