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BakerHostetler LLP
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Healthcare: Pharmaceutical/Medical Products Regulatory

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

4
Band 4

What the Team is Known For

BakerHostetler LLP has notable experience in high-profile FDA mandates. Regularly advises pharmaceutical clients and providers as well as private equity funds on regulatory issues such as those connected to new drug applications and advertising matters. Expertise in negotiating pharmacy benefit management contracts. Also offers strong skills in a broad range of transactions including sale of assets and joint ventures.

Work Highlights

  • BakerHostetler LLP represented the Outsourcing Facility Association in a lawsuit against HHS and the FDA, seeking to compel the FDA to act on hundreds of pending nominations for active pharmaceutical ingredients for outsourcing facilities compounding drugs. It alleges the FDA’s inaction violated the Administrative Procedure Act.

Strengths

Provided by Chambers

The BakerHostetler team has excellent pharmaceutical industry knowledge, is exceedingly responsive to challenging regulatory issues and is keenly aware of key commercial issues that affect the market.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

BakerHostetler has a comprehensive understanding of all things FDA. It is well organized in its approach to finding equitable resolutions.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

The firm has a deep understanding of the healthcare industry and connections with key industry stakeholders; it has commercially-focused attorneys who have a deep appreciation of our business.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

The firm has in-depth regulatory expertise, federal and state contracting acumen and excellence in promptness. It provides exceptional service.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Notable Practitioners

Provided by Chambers

Lee H Rosebush
3
Lee H Rosebush
3
Band 3
Lee Rosebush has noted expertise in FDA-related compliance issues such as new drug applications and licensing matters. He regularly provides advice to clients in the 503B outsourcing space and has broad knowledge of transactional issues.

Lee handles even the most complex pharmacy regulatory issues with professionalism and agility. He is sharp, reliable and understands technical details, along with the anticipation of industry shifts.

Lee is straightforward and practical about his approach. He has strong relationships with the FDA, and so brings a level of knowledge that is hard to beat.

It is always a pleasure working with Lee. He is very professional in his approach at the same time, very transparent. He is very knowledgeable of regulatory law.

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Marc N Wagner
Marc N Wagner
Star Associates

Marc Wagner of BakerHostetler LLP is recognized as a star associate for his ability to handle a broad spectrum of FDA and DEA issues, including regulatory support, investigations and litigation. His clients include pharmaceutical and healthcare organizations.

Marc is a very impressive lawyer who continues to demonstrate a deeper understanding of the healthcare regulatory space. His commitment to customer service is very impressive

With a dual background in both law and pharmacy, Marc has an invaluable unique insight that elevates the quality and practicality of his legal advice and services.

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Ranked Lawyers at
BakerHostetler LLP

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District of Columbia

Healthcare: Pharmaceutical/Medical Products Regulatory
Lee H Rosebush
3
Lee H Rosebush
3
Band 3
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Marc N Wagner
Marc N Wagner
Star Associates
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