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    Home > Active Ingredient News > Drugs Articles > FDA Director: The biomedical industry should focus on the development of innovative therapies in these areas of global regulatory dynamics

    FDA Director: The biomedical industry should focus on the development of innovative therapies in these areas of global regulatory dynamics

    • Last Update: 2022-09-09
    • Source: Internet
    • Author: User
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    The FDA director noted that the biomedical industry should focus on the development of therapies for chronic and addictive diseases

    The FDA director noted that the biomedical industry should focus on the development of therapies for chronic and addictive diseases

    Recently, DR.


    While progress has been made in treating cancer and rare diseases, the decline in life expectancy in the United States has been largely driven by common chronic diseases, including cardiometabolic diseases, lung disease, kidney disease, and mental health problems


    Declines in life expectancy are primarily driven by common chronic diseases, which include cardiometabolic diseases, lung disease, kidney disease, and mental health problems


    The biomedical industry should re-examine the existing means of development and the focus of research and development for these diseases in order to develop more innovative therapies in these areas


    Consortia, a consortium of patients, researchers, regulators and the medical product industry, is also an important part


    Related Links:

    How can I improve the use of FDA Advisory Boards? Harvard experts made three suggestions

    How can I improve the use of FDA Advisory Boards? Harvard experts made three suggestions

    The FDA Advisory Committee is comprised of external independent experts convened by the FDA to provide advice and recommendations to fda on science, technology, and policy-related matters


    Recently, three scholars from Harvard University's Regulatory, Medical and Legal Program (PORTAL) published an article in the New England Journal of Medicine, saying that the FDA can adopt the following three initiatives to improve the use of FDA advisory committees:

    1.


    FDA may issue guidance explaining the specific conditions


    Questions that need to be answered by the committee are published in advance before the advisory board meets, and for meetings involving approval of medical products, the FDA can design a standardized question structure


    Establish a public mechanism to explain the reasons for


    Related links: DOI: 10.


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    First update in 14 years! The European Union publishes the latest GMP guidelines for the manufacture of sterile pharmaceuticals

    First update in 14 years! The European Union publishes the latest GMP guidelines for the manufacture of sterile pharmaceuticals

    A few days ago, the European Union issued the latest GMP guidelines


    Manage the manufacture of sterile pharmaceutical products in the EU, as well as imported products


    Most of this guidance will take effect on August 25,


    Related links: https://health.


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    Increased use of the European Medicines Agency's Clinical Trial Information System (CTIS).


    Increased use of the European Medicines Agency's Clinical Trial Information System (CTIS).

    The European Medicines Agency (EMA) has released a report
    on the use of the new Clinical Trials Information System (CTIS), which was launched earlier this year.
    CTIS is EMA's newly launched clinical trial filing, review and management system
    .
    Since January 31 this year, the EMA has encouraged all sponsors of clinical trials to submit clinical trial information
    through this system.

    CTIS is EMA's newly launched clinical trial filing, review and management system
    .
    Since January 31 this year, the EMA has encouraged all sponsors of clinical trials to submit clinical trial information
    through this system.

    As of July 31 this year, a total of 195 clinical trial applications have been submitted through CTIS, including 188 initial clinical trial applications, and a total of 43 clinical trials have been licensed
    .
    However, 224 clinical trial applications were still submitted through the previous EudraCT database during the
    same period.

    The EMA said the new CTIS system is conducive to improving information sharing, clinical trial transparency, helping joint decision-making in clinical trials and ensuring the security of
    patient information.
    It also enables clinical trial sponsors to conduct multiple clinical trials
    simultaneously in the EU based on the same document.

    The newly introduced CTIS system helps to improve information sharing, transparency in clinical trials, facilitate joint decision-making in clinical trials, and ensure the security of
    patient information.
    It also enables clinical trial sponsors to conduct multiple clinical trials
    simultaneously in the EU based on the same document.

    In January 2023, CTIS will replace EudraCT as a mandatory system
    for clinical trial sponsors.

    Related links:

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