Search Results for keywords:"21 CFR 10.20"

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Search Results: keywords:"21 CFR 10.20"

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  • 2021-00125 — Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
    Type:Notice
    Citation:86 FR 1508
    Reading Time:about 8 minutes

    The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to recalls of products that the agency regulates, in accordance with the Paperwork Reduction Act (PRA) of 1995. Comments can be submitted either electronically or in written form by March 9, 2021. The FDA aims to gather feedback on various aspects like the necessity and effectiveness of the information collection, and possible ways to make the process easier. The submission and monitoring of recall information help ensure the proper removal or correction of recalled products.

    Simple Explanation

    The FDA wants to hear from people about how they manage recalls, or taking back products that might not be safe, to make sure they're doing it right. They ask for you to tell them what you think by early March, and they're looking for ideas on how to improve their process.

  • 2024-31262 — Determination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE
    Type:Notice
    Citation:89 FR 106492
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has determined the regulatory review period for a human biologic product named OMISIRGE, which is used for treating certain blood cancers. The review period, which is 4,563 days long, involves a testing phase and an approval phase and influences the potential extension of the product's patent. The FDA's decision follows an application by Gamida Cell Ltd. for patent extension, and the public can provide comments or request further determinations by specified deadlines.

    Simple Explanation

    The FDA looked at how long it took to check and approve a special medicine called OMISIRGE that helps fight some blood cancers. They found that this took a long time, and now they're thinking about giving the makers a little more time for their special recipe (patent) to stay theirs and not be copied by others.