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    Regulatory Affairs Sagar

    Uploaded by

    Manish shankarpure
    This document contains a practice question bank for regulatory affairs with 5 multiple choice questions. The questions cover topics like bioequivalence requirements for ANDAs, NDA application types for drug combinations, what the 600 series of 21 CFR deals with, what the Hatch-Waxman Act framework includes, and the certification clause that allows filing an ANDA before expiry.

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    Regulatory Affairs Sagar

    Uploaded by

    Manish shankarpure
    964 views1 page
    This document contains a practice question bank for regulatory affairs with 5 multiple choice questions. The questions cover topics like bioequivalence requirements for ANDAs, NDA application types for drug combinations, what the 600 series of 21 CFR deals with, what the Hatch-Waxman Act framework includes, and the certification clause that allows filing an ANDA before expiry.

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    This document contains a practice question bank for regulatory affairs with 5 multiple choice questions. The questions cover topics like bioequivalence requirements for ANDAs, NDA application types for drug combinations, what the 600 series of 21 CFR deals with, what the Hatch-Waxman Act framework includes, and the certification clause that allows filing an ANDA before expiry.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    964 views1 page

    Regulatory Affairs Sagar

    Uploaded by

    Manish shankarpure
    This document contains a practice question bank for regulatory affairs with 5 multiple choice questions. The questions cover topics like bioequivalence requirements for ANDAs, NDA application types for drug combinations, what the 600 series of 21 CFR deals with, what the Hatch-Waxman Act framework includes, and the certification clause that allows filing an ANDA before expiry.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    Regulatory Affairs

    PRACTICE QUESTION BANK

    1) . As per ANDA requirements the bioequivalence of test to reference formulation is _________

    a. 80-120%

    b. 100-150%

    c. 70-130%

    d. 70-80%

    2) Name the type of NDA application that needs to be filed in united states for combination of two
    or more active moieties

    a. Type 2

    b. Type 4

    c. Type 5

    d. Type 6

    3) The 600 series in the Chapter 1 of 21 CFR deals in

    a. cGMP

    b. Cosmetics

    c. Biological products

    d. OTC drugs

    4. Hatch-Waxman Act framework includes

    a. Approve manufacturing of sutures and ligatures

    b. Streamlining the process for branded pharmaceutical products

    c. Streamlining the process for generic pharmaceutical approvals

    d. Approve medical devices

    5) . A competitor can file for ANDA before its expiry under _______ clause of ANDA certification
    clause

    a. Para I

    b. Para II

    c. Para III

    d. Para IV

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