Search Results for keywords:"Pharmaceuticals"

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Search Results: keywords:"Pharmaceuticals"

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  • 2021-03399 — Foreign-Trade Zone (FTZ) 266-Dane County, Wisconsin; Authorization of Production Activity; Coating Place, Inc. (Pharmaceuticals); Verona, Wisconsin
    Type:Notice
    Citation:86 FR 10243
    Reading Time:less than a minute

    Coating Place, Inc. applied to the Foreign-Trade Zones Board to conduct production activities at its plant in Verona, Wisconsin, part of FTZ 266. The request was processed following FTZ Board regulations, and a notice was published in the Federal Register for public comments. On February 16, 2021, the FTZ Board decided that the proposed production activities did not require further review. Consequently, the production activities were authorized, adhering to the FTZ Act and the board's regulations.

    Simple Explanation

    A company called Coating Place, Inc. in Wisconsin asked for permission to make medicine in a special business area. Some people checked and said it’s okay, so now they can go ahead and do it.

  • 2024-31027 — M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability
    Type:Notice
    Citation:89 FR 106504
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development." This document was created under the International Council for Harmonisation (ICH) and provides recommendations on planning, evaluating, and documenting evidence in drug development using models. It aims to help harmonize regulations globally, enhancing drug development and improving manufacturing standards. Public comments on the draft can be submitted until February 28, 2025.

    Simple Explanation

    The FDA wrote a guide to help scientists use special models when making new medicines, so everyone around the world can agree on the best ways to do this. People can share their thoughts about it until February 2025, but the guide might be a little tricky to understand because it uses big words and doesn't always explain what they mean.