Shoshana advises clients on the legal and regulatory landscape for matters that fall within the jurisdiction of the US Food and Drug Administration (FDA), Department of Agriculture (USDA), Environmental Protection Agency (EPA), and their state counterparts.
Examples of her work include:
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Providing guidance on the newly established FDA Over-The-Counter Monograph Drug User Fee Program
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Counseling on compliance with the federal Clinical Laboratory Improvement Amendments (CLIA) and state laboratory licensing requirements
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Advising on FDA monitoring and enforcement of EPA pesticide residue tolerances
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Providing advice regarding the regulatory framework for the care and use of research animals
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Counseling on FDA classification of and applicable requirements for medical devices
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