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Life Sciences: Regulatory/Compliance

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Life Sciences: Regulatory/Compliance - USA - Nationwide

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What the Team is Known For

Hogan Lovells enjoys a strong reputation for its roster of regulatory attorneys who offer guidance on compliance, approval processes and contentious engagements with government agencies. The firm has additional expertise in pharmaceutical and medical device product liability proceedings. It also advises on business development, clinical trials, capital markets transactions and strategic partnerships.

Work Highlights

  • Hogan Lovells represented Danco Laboratories, manufacturer of Mifeprex (mifepristone), in a lawsuit seeking to revoke the FDA’s approval of the drug.

Strengths

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The Hogan Lovells team is knowledgeable, professional and communicative.

Life Sciences: Regulatory/Compliance respondent
USA

First and foremost is the breadth and depth of the team's actual experience on regulatory matters - it is unmatched by any other firm.

Life Sciences: Regulatory/Compliance respondent
USA

Notable Practitioners

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David Fox
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David Fox is well versed in FDA review procedures for new products and Hatch-Waxman compliance issues. He offers further experience in related intellectual property matters and product life cycle management.

David is a wonderful partner for exploring issues, discussing strategy and ensuring execution.

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Philip Katz
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Philip Katz is a seasoned guide for startups and public companies in the biotech and pharmaceuticals industries, frequently assisting clients in the navigation of FDA and other regulatory frameworks. He is well versed in Hatch-Waxman, orphan drug and biosimilars issues and is adept at representing clients in court and before various regulators.

Not only does Philip have the experience every pharma company needs, he has long developed relationships at the FDA in a variety of disciplines, all of which are especially useful for the client.

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Ranked Lawyers at
Hogan Lovells

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USA - Nationwide

Life Sciences: Regulatory/Compliance
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David Fox
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3
Philip Katz
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Band 3
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