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Jacqueline R. Berman

パートナー

She/Her/Hers

Jacqueline Berman advises companies throughout the US Food and Drug Administration (FDA)–regulated product supply chain on regulatory and compliance requirements. Jacqueline helps clients navigate complex issues associated with development, approval, and commercialization of prescription and non-prescription pharmaceuticals and biologics, including vaccines, and cell and gene therapies. Jacqueline further counsels clients on legal requirements under laws enforced by the US Consumer Product Safety Commission, Federal Trade Commission, US Drug Enforcement Agency, and state licensing agencies for consumer products, controlled substances, pharmaceuticals, and medical devices.

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2023 Drugs and Biologics Year in Review:
Will FDA's 2023 Evolution Usher in Swift Resolutions for 2024?

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As Prescribed
YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

    詳細

    規制対象製品のFDA承認を取得して製品の上市を可能にし、法律規制の遵守を維持すると共に、新規及び既存の治療薬を必要としている患者に製品が確実に提供されるよう、クライアントを支援します。その助言は、規制手続や開発の迅速化戦略に関するカウンセリング、規制当局との交渉、臨床試験及び臨床前試験の実施、研究倫理、製品の製造、品質管理、製品流通、製品ラベル表記、プロモーション、マーケティングや広告に及びます。

    更に、検査上の不備、FDAからの無題書簡及び警告書、リコール、その他の執行措置、競合他社からの商取引に係る苦情、内部調査等の規制に関する重大な案件や課題を抱えた企業を支援します。クライアントは、バイオ医薬品の大手や新興企業、物流業者、卸売業者、薬局や小売業者等です。FDA関連法務に加えて、麻薬取締局や州の定める要件を規制物質や指定化学物質の製造業者、流通業者、及び調剤薬局が理解し遵守するよう助言しています。

    また、食品医薬品法研究所のメンバーとして長年多数の委員会で積極的に活動してきました。ライフサイエンス業界が直面する問題について数多くの著作、講演の実績があります。バーマンはLMGライフサイエンスによる南北アメリカ地域規制部門で米国ライジングスターに選出されています。

    selected representations

    • Assisted in responding to FDA, DEA, and state enforcement actions, including inspectional findings and assertions of non-compliance
    • Supported numerous biopharmaceutical companies in initial public offerings, re-offerings, public filings, and merger and acquisition transactions, including regulatory due diligence, agreement negotiation, and drafting filings
    • Supported multiple companies seeking marketing approval of innovative and new biopharmaceutical products in their interactions, submissions, and negotiations with FDA
    • Assisted OTC, dietary supplement, and medical device manufacturers in the review and establishment of internal quality and compliance programs
    • Advised numerous companies on regulatory issues and questions concerning pre-clinical and clinical product development, including compliance with good clinical practices, conflicts of interest, NIH grants and compliance requirements, subject informed consent, and institutional review board approval
    • Counseled numerous companies on regulatory pathways and life cycle management strategies, including orphan drug designations, fast track designations, accelerated approvals, breakthrough therapy designations, regenerative medicine designations, regulatory exclusivity, and patent term extension
    • Advised companies developing new and innovative therapeutic technologies, including cell and gene therapies, as well as companies using new development and manufacturing technologies, including artificial intelligence on FDA-regulatory requirements, pathways, and options
    • Drafted and negotiated agreements for all levels of the life sciences supply chain, including manufacturing, quality, distribution, purchase and supply, and clinical trial agreements
    • Assisted companies in understanding and developing systems and processes to comply with evolving legal and regulatory requirements, including requirements under the Drug Supply Chain Security Act and the Controlled Substances Act

    学歴

    • 2006年 American University (B.A. Phi Beta Kappa 優等生)
    • 2009年 ジョージワシントン大学ロー・スクール (J.D. 最優秀)

    弁護士登録

    • コロンビア特別区
    • メリーランド州

    受賞・所属

    2021年、LMGライフサイエンス、南北アメリカ地域、規制部門で米国ライジングスターに選出

    2021年、LMGライフサイエンス、規制部門でライフサイエンススターに選出

    2022年、食品医薬品法研究所、臨床試験会議企画委員会、委員

    2021年、食品医薬品法研究所、ウェビナー委員会、委員

    2018～2019年、食品医薬品法研究所編集委員

    著書・論文

    ニュース

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