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Good Manufacturing Practices

54 published works

  1. Drug & Device Law

    CGMPs:  Changing Good Manufacturing Practices (and Preemption)

    By Lisa Baird

    In the drug and device product liability world, we love our acronyms and our short-hand phrases.  The MDAs to the FDCA.  Class III.  PMA.  510(k). Today’s acronym is CGMP, which…

  2. Food Safety News

    FDA issues warning letter to producer that supplies food for school lunch programs

    By News Desk

    As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or…

  3. BioSlice Blog

    EU Consults on New GMP Rules for AI in Pharma Manufacturing

    By Alexander Roussanov, Anna Pothof

    On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing.…

  4. China Law Insight

    动物保健:兽药GMP

    By King & Wood

    作者:陈兵 李昊原 上篇(动物保健:兽药注册的全流程与要点分析)中,我们总览性地介绍兽药注册的全流程并分析了形式审查和实质审查阶段的若干要点,本篇中,我们将聚焦兽药生产板块。 阅读更多

  5. Product Perspective: Complex Tort & Product Law

    MoCRA: Good Manufacturing Practices – Why Should You Care?

    By Magda Patitsas, Jen Dlugosz, Seth Mailhot

    As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series…

  6. Food Safety News

    Food firm in China warned by FDA over violations of federal food regulation

    By News Desk

    As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or…

  7. Food Safety News

    Ready-to-eat bakery facility warned over pest problems in facility

    By News Desk

    As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or…

  8. The Daily Intake

    FDA Announces Public Meeting on Good Manufacturing Practices for Cosmetic Products

    By Keller and Heckman LLP

    Today, FDA announced that it will be holding a virtual listening session on June 1, 2023 for interested parties to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations,…

  9. The Daily Intake

    FDA Finalizes Guidance to Prevent Unsafe Contamination of Animal Feed from Drug Carryover

    By Keller and Heckman LLP

    While FDA’s Center for Veterinary Medicine (CVM) accepts that absolute avoidance of all batch-to-batch drug carryover may not be possible in the production of animal feed, CVM’s “Current Good Manufacturing…

  10. Food Safety News

    California food firm warned after rodents, cats, bats, roaches and more found in warehouse

    By News Desk

    As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or…