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    New Drug Application: Presented By: Amey Deshpande

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    amey_dpd
    The New Drug Application (NDA) is the process through which drug sponsors formally propose to the FDA for approval to sell and market a new pharmaceutical. The goals of the NDA are to demonstrate the drug's safety, efficacy, that its benefits outweigh the risks, and that its labeling and manufacturing are adequate. Sponsors must first obtain an Investigational New Drug (IND) approval to legally test the drug on humans through clinical trials in phases to study safety, efficacy, and effectiveness. The NDA application provides documentation of the clinical trials and drug ingredients, formulation, manufacturing, and labeling for FDA review and potential approval to legally market the new drug.

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    New Drug Application: Presented By: Amey Deshpande

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    amey_dpd
    338 views14 pages
    The New Drug Application (NDA) is the process through which drug sponsors formally propose to the FDA for approval to sell and market a new pharmaceutical. The goals of the NDA are to demonstrate the drug's safety, efficacy, that its benefits outweigh the risks, and that its labeling and manufacturing are adequate. Sponsors must first obtain an Investigational New Drug (IND) approval to legally test the drug on humans through clinical trials in phases to study safety, efficacy, and effectiveness. The NDA application provides documentation of the clinical trials and drug ingredients, formulation, manufacturing, and labeling for FDA review and potential approval to legally market the new drug.

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    New Drug Application

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    The New Drug Application (NDA) is the process through which drug sponsors formally propose to the FDA for approval to sell and market a new pharmaceutical. The goals of the NDA are to demonstrate the drug's safety, efficacy, that its benefits outweigh the risks, and that its labeling and manufacturing are adequate. Sponsors must first obtain an Investigational New Drug (IND) approval to legally test the drug on humans through clinical trials in phases to study safety, efficacy, and effectiveness. The NDA application provides documentation of the clinical trials and drug ingredients, formulation, manufacturing, and labeling for FDA review and potential approval to legally market the new drug.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    338 views14 pages

    New Drug Application: Presented By: Amey Deshpande

    Uploaded by

    amey_dpd
    The New Drug Application (NDA) is the process through which drug sponsors formally propose to the FDA for approval to sell and market a new pharmaceutical. The goals of the NDA are to demonstrate the drug's safety, efficacy, that its benefits outweigh the risks, and that its labeling and manufacturing are adequate. Sponsors must first obtain an Investigational New Drug (IND) approval to legally test the drug on humans through clinical trials in phases to study safety, efficacy, and effectiveness. The NDA application provides documentation of the clinical trials and drug ingredients, formulation, manufacturing, and labeling for FDA review and potential approval to legally market the new drug.

    Copyright:

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    Download as PPT, PDF, TXT or read online from Scribd
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    of 14

    New Drug Application

    Presented By: Amey Deshpande


    Overview
    1. What is NDA?
    2. Goals of NDA
    3. Process of NDA in Brief
    4. Investigational New Drug (IND)
    5. Process of IND
    6. Clinical Trials
    7. Clinical Trials, IND and NDA
    8. The actual application
    9. NDA Process
    10. Requirements for similar products
    11. ANDA Process
    What is NDA?
    The New Drug Application (NDA) is the
    procedure through which drug
    sponsors formally propose the FDA
    to approve a new pharmaceutical for
    sale and marketing
    Goals of NDA
    The goals of the NDA are to provide enough
    information to FDA to establish the following:
    1.safety and efficacy of drug in its proposed use
    when used as directed
    2. benefits of the drug outweighs the risks
    3. the drug’s proposed labeling is appropriate,
    and has what it should contain
    4.The methods used in manufacturing the drug
    and the controls used to maintain the drug’s
    quality are adequate to preserve the drug’s
    identity, strength, quality, and purity
    Process of NDA in Brief

    Advisory committee
    Investigational New Drug (IND)
    • To legally test the drug on human subjects,
    the maker must first obtain an Investigational
    New Drug (IND) approval from FDA
    • This application is based on pre-clinical
    data, typically from animal studies, that
    shows the drug is safe enough to be
    tested in humans
    • Often the "new" drugs that are submitted are
    not new molecular entities, but old
    medications that have been modified
    Process
    of IND
    Clinical Trials
    The trials are typically conducted in following phases:
    • Phase 1: The drug is tested in a small (20-50)
    group of healthy volunteers for toxicity (Safety)
    • Phase 2: Safety and Efficacy testing
    • Phase 3: The drug is typically tested in double-
    blind, placebo controlled trials to demonstrate
    that it works
    **Sponsors typically confer with FDA prior to starting
    these trials to determine what data is needed, since
    these trials often involve hundreds of patients and
    are very expensive
    • Phase 4: These are post-approval trials that are
    sometimes a condition attached by the FDA to the
    approval
    Clinical Trial, IND and NDA
    The actual application
    • The results of the testing program are entered in an
    FDA-approved public document that is called the
    product label,
    • The documentation required in an NDA is supposed
    to tell the drug’s whole story, including
    – what happened during the clinical tests
    – what the ingredients of the drug formulation are
    – the results of the animal studies,
    – how the drug behaves in the body
    – and how it is manufactured, processed and packaged.
    • Once approval of an NDA is obtained, the new drug
    can be legally marketed starting that day
    NDA
    Process
    Requirements for similar products
    • Biologics, such as vaccines are generally
    approved by FDA via a Biologic License
    Application (BLA), rather than an NDA
    • Generic drugs that have already been approved
    via an NDA submitted by another maker are
    approved via an
    Abbreviated New Drug Application (ANDA), which
    does not require all of the clinical trials normally
    required for a new drug in an NDA.
    • Medical devices are approved by a variety of
    methods depending on the class of the device. A
    Pre-market Application (PMA) largely equivalent
    to an NDA
    ANDA
    Process
    Any Questions??...

    Thank You!!

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