Search Results for keywords:"drug registration"

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Search Results: keywords:"drug registration"

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  • 2024-30355 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
    Type:Notice
    Citation:89 FR 104188
    Reading Time:about 10 minutes

    The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to the registration of drug producers and the listing of drugs in commercial distribution. This effort supports the implementation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and aims to maintain up-to-date drug information to ensure public health. Key updates include exemptions for certain biological products under new guidelines resulting from the CARES Act and recommendations for emergency planning to maintain drug supply. The public can provide feedback by January 21, 2025, through the specified OMB website link.

    Simple Explanation

    The FDA wants to know what people think about new rules for how drug makers register their companies and list their drugs, to make sure medicine is safe and available. People can share their thoughts online by January 21, 2025.

  • 2025-01349 — Bulk Manufacturer of Controlled Substances Application: Groff Health, Inc.
    Type:Notice
    Citation:90 FR 7172
    Reading Time:about a minute or two

    Groff Health, Inc. has applied to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. People can submit electronic comments or objections regarding this application by March 24, 2025. Comments must be submitted through the Federal eRulemaking Portal, and commenters will receive a tracking number to confirm successful submission. The company plans to produce these substances for internal use or sale but is not authorized for other activities related to these drug codes.

    Simple Explanation

    Groff Health, Inc. wants permission from the government to make certain special medicines, and people have until March 24, 2025, to say if they think it's a good or bad idea.