ARTICLES BY KALAH AUCHINCLOSS

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    The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act
    2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

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    US Congress Passes Bill Supporting New Era of Biopharma Advanced & Continuous Manufacturing
    1/5/2022

    The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.

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    FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History
    9/10/2021

    On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. It provides clarity to manufacturers, but many remain dissatisfied with the evidentiary standard for determining intended use. Might legal challenges follow?

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    The “Resiliency Roadmap” — Next Steps For FDA Inspections
    6/11/2021

    More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.

Kalah Auchincloss

Kalah Auchincloss, J.D., M.P.H., is SVP of regulatory compliance and deputy general counsel for Greenleaf Health. She has more than a decade of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. At Greenleaf, Auchincloss advises pharmaceutical and medical device companies on compliance, policy, and other issues. Before moving to Greenleaf, Auchincloss spent six years at the FDA, most recently as deputy chief of staff, but also serving in CDER’s Office of Compliance and Office of Regulatory Policy. You can contact her at kalah.auchincloss@greenleafhealth.com.