Search Results for keywords:"research and clinical trials"

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Search Results: keywords:"research and clinical trials"

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  • 2024-28715 — Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
    Type:Notice
    Citation:89 FR 97069
    Reading Time:about a minute or two

    Kinetochem LLC has filed an application to be registered as a bulk manufacturer of certain controlled substances. The company plans to manufacture these substances, including synthetic versions of Marihuana and Tetrahydrocannabinols, for use as Active Pharmaceutical Ingredients in research and clinical trials. The public or other manufacturers may submit comments or objections electronically by February 4, 2025, through the Federal eRulemaking Portal.

    Simple Explanation

    Kinetochem LLC wants to make special, strong medicines from things like Marihuana for doctors and researchers to use in tests. People have until February 4, 2025, to tell the government if they think this is a good or bad idea.

  • 2025-03635 — Importer of Controlled Substances Application: Indivior Inc.
    Type:Notice
    Citation:90 FR 11438
    Reading Time:about a minute or two

    Indivior Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. They intend to import these substances in limited quantities for use in research, clinical trials, and for developing the manufacturing process of dosage forms. Comments or objections regarding this application can be submitted electronically by April 7, 2025, and requests for a hearing can also be made by that date. The DEA requires that comments be submitted through their online portal.

    Simple Explanation

    Indivior Inc. wants permission from the DEA to bring in small amounts of certain drugs from other countries. They need these drugs to do tests and learn how to make new medicines, and people can tell the DEA if they think this is a good or bad idea by April 7, 2025.