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    Review of Literature For Us-Fda and It'S Applications in India

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    Kaustubh Karve
    US-FDA, the Regulatory authority of United States of America who approves the new pharmaceutical products. this is an overview of how US-FDA has formed and different clauses of US-FDA.

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    Review of Literature For Us-Fda and It'S Applications in India

    Uploaded by

    Kaustubh Karve
    53 views14 pages
    US-FDA, the Regulatory authority of United States of America who approves the new pharmaceutical products. this is an overview of how US-FDA has formed and different clauses of US-FDA.

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    US-FDA

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    US-FDA, the Regulatory authority of United States of America who approves the new pharmaceutical products. this is an overview of how US-FDA has formed and different clauses of US-FDA.

    Copyright:

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

    Review of Literature For Us-Fda and It'S Applications in India

    Uploaded by

    Kaustubh Karve
    US-FDA, the Regulatory authority of United States of America who approves the new pharmaceutical products. this is an overview of how US-FDA has formed and different clauses of US-FDA.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    You are on page 1of 14

    REVIEW OF LITERATURE

    FOR US-FDA AND IT’S


    APPLICATIONS IN INDIA

    -Kaustubh Karve
    What is FDA?

    • FDA is a federal science-


    based law enforcement
    agency mandated to protect
    public health and safety.
    HISTORICAL PERSPECTIVE
    •1820-U.S.Pharmacopeia
    •1848-Drug importation act
    •1902-Biological control act
    •1906-Food and Drug act
    •1933-Revision of 1906 FDA
    •1937-Elixir of Sulfanilamide
    •1938-FDC act
    •1940-FDA transferred to federal security agency
    •1944-Public Health Service Act
    •1951-Durham-Humphrey Amendment
    • 1962-(Thalidomide) Kefauver-Harris Drug
    Amendments
    • 1976-Medical Device Amendments
    • 1983-Orphan Drug Act
    • 1988-Food and Drug Administration Act
    • 1992-Prescription Drug User Fee Act
    • 1997-Food and Drug Administration Modernization
    Act
    • 2002-Public Health Security and Bioterrorism
    Preparedness and Response Act
    • 2005-Formation of the Drug Safety Board
    FDA’s Mission
    •To promote and
    protect public health

    •To monitor product


    for continued safety

    •To help the public


    get accurate
    science- based
    information.
    What FDA regulates?
    • Biologics
    • Cosmetics
    • Drugs
    • Foods
    • Medical devices
    • Radiation-emitting electronic devices
    • Veterinary products
    What FDA does not regulate?

    • Water (EPA)
    • Alcohol (ATF)
    • Pesticides (EPA)
    • Advertising (FTC)
    • Drug of abuse (DEA)
    • Meat & Poultry (FSIS)
    • Health Insurance (CMMS)
    • Consumer products (CPSC)
    • Restaurants & Grocery stores
    Role in Clinical Trial
    • Investigational New Drug

    • New Drug Application

    • Abbreviated New Drug Application

    • Drug Master Files


    IND Review Process
                                                                                                                          
    Making Your Voice Heard at FDA
    • In general, any citizen can
    submit comments on rules FDA proposes.

    • FDA gathers public comments mainly


    through two channels:
     Proposed rules
     Petitions
    FDA APPROVED INDIAN DRUGS

    • Atenelol- Hypertension-
    Ranbaxy

    • Amitriptyline
    Hydrochloride &
    Lorazepam- Psychiatric-
    RL Fine Chemicals

    • Tykerb or Lapatinib-
    Breast cancer- GSK
    • Zolipedam Tartarate-
    Insomnia- Ranbaxy
    (tentative approval)

    • Sertraline- Depression-
    Lupin Pharma Ltd.

    • Doxycycline- Antibiotic
    -Ranbaxy

    • Citalopram-Depression-
    Aurobindo Pharma Ltd
    THANK YOU
    Science and peace will triumph over
    ignorance and war,
    Nations will unite, not to destroy,
    But to build, and the future
    Will belong to those
    Who will have done most
    For suffering humanity….
    -Louis Pasteur

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