Search Results for keywords:"FDA notice"

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Search Results: keywords:"FDA notice"

  • Type:Notice
    Citation:90 FR 11984
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.

    Simple Explanation

    Jonathan got in trouble for selling fake medicine, so the government said he can't bring any medicine into the country for ten years. He was given a chance to explain, but he didn't say anything, so now this rule is set.

  • Type:Notice
    Citation:86 FR 1510
    Reading Time:about 10 minutes

    The Food and Drug Administration (FDA) is asking consumer organizations interested in selecting representatives for its advisory committees to notify the FDA in writing. They are also requesting nominations for consumer representatives, either voting or non-voting, for committees with current or upcoming vacancies. The FDA encourages diverse nominations, highlighting a desire for representation from various demographics, including racial and ethnic groups, as well as individuals with disabilities. The selection process involves organizations recommending nominees, and the FDA will compile a list of qualified candidates based on the recommendations received.

    Simple Explanation

    The FDA is asking people to help pick special helpers, called consumer representatives, who give advice on important groups. They want helpers from all kinds of different backgrounds, but it's hard for people who don't know how the process works to get involved.

  • Type:Notice
    Citation:89 FR 106521
    Reading Time:about 2 minutes

    The Food and Drug Administration (FDA) has announced it will transfer regulatory responsibility for medical maggots and medicinal leeches from the Center for Devices and Radiological Health (CDRH) to the Center for Biologics Evaluation and Research (CBER), effective December 30, 2024. This decision was made because these products are living organisms, and CBER is more suited to regulate such products. The transfer only affects which FDA Center will oversee these products and does not change any existing requirements. After the transfer date, all submissions related to these products should be directed to CBER.

    Simple Explanation

    The FDA decided that medical maggots and leeches, which are tiny creatures used to help heal people, will now be looked after by a different part of the FDA because they are living things. This change happens at the end of 2024 and doesn't change any of the current rules for using them.