전 FDA 법률 고문 Kristin Kaplan이 'Shook, Hardy & Bacon'에 합류하여 회사의 규제 역량을 더욱 확장했다. Kaplan은 8년 동안 FDA에 자문을 제공하고, 동물 건강분야의 글로벌 리더에서 사내 역할을 맡기 전에 정부 기관의 규제 문제와 뉘앙스를 깊이 이해하고 있다.
Kaplan은 생명공학 및 식품, 동물성 식품 및 의약품 리콜에서 비롯된 새로운 동물의약품 적용을 포함한 다양한 문제에 대해 FDA 커미셔너에게 자문을 제공했다. 나중에 그녀는 세계 최대의 동물건강 리더 중 한 사람의 법률 고문이 되어 규제, 규정 준수, 건강, 안전 및 환경 문제를 비롯한 다양한 문제에 대한 전략적 통찰력을 제공했다. 또한 그녀는 회사의 코로나19 대응에 대한 직접적인 글로벌 법률 지원을 제공했다.
Former Food & Drug Administration Associate Chief Counsel Kristin Kaplan joins Shook, Hardy & Bacon, further expanding the firm's regulatory capabilities. Kaplan has a deep understanding of regulatory issues and the nuances of the government agency after she advised the FDA for eight years, and before taking an in-house role at a global leader in animal health.
"Her combined FDA insight and in-house experience make Kristin invaluable as we deepen our regulatory capabilities," said Shook Chair Madeleine McDonough, who divides her time between Washington, D.C. and Kansas City. "It is critical for our clients facing litigation to align with our regulatory team to anticipate and address developing legal developments."
Kaplan counseled FDA Commissioner on a variety of issues including new animal drug applications stemming from biotechnology and recalls of foods, animal foods and drugs. She later became Deputy General Counsel for one of the world's largest animal health leaders where she provided strategic insight on various issues including regulatory, compliance, and health, safety and environment matters. In addition, she provided direct global legal support for the company's COVID-19 response.
"Given the new Administration and pending announcement of a new commissioner, it's extremely important that businesses recognize priorities may shift whether that's enforcement or COVID," said Kaplan. "I am well-positioned to impart the lessons learned on what resonates with the FDA and what does not."
Kaplan was drawn to Shook for its stellar legal reputation and commitment to diversity. Women compose 45 percent of the firm's Executive Committee, lead six of the firm's offices and make up a third of practice group leadership.
"Having known Shook lawyers over the years, I've always been impressed with its advancement of women lawyers from the top down," said Kaplan, who was a 2016 Leadership Council on Legal Diversity Fellow. "That was important to me."
Shook lawyers capitalize on decades of industry experience to solve complex legal challenges related to the development of a product, bringing it to market and post-market enforcement. Shook attorneys have deep experience with the FDA and represent some of the world's best known brands in the agriculture, food and beverage, personal care and pharmaceutical industries. The firm has represented more than 40 FDA-regulated companies as national or regional counsel.
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