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FDA/Regulatory Group
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Introduction

Frommer Lawrence & Haug's (FLH's) FDA/Regulatory Group excels in advising and representing companies in matters covering all FDA-regulated products--foods, drugs, biologics and biosimilars, medical devices, cosmetics, dietary supplements, and tobacco products.

The Group provides a broad variety of services relating to (1) pre-market approval applications, (2) life cycle management, (3) labeling, advertising and promotion, (4) good manufacturing practice requirements, (5) product safety issues, such as risk evaluation and mitigation and evaluation strategies (REMS), and (6) imports and exports. Our experience includes drafting comments on proposed FDA regulations, bringing court challenges to FDA rules and statutory interpretations, crafting responses to FDA warning letters, addressing FDA inspections and recalls, and representing companies in seizures, criminal proceedings, injunctions, and appeals.

Attorneys in the Group have worked in FDA's Office of the Commissioner, Office of Chief Counsel, and Center for Drug Evaluation and Research, which have provided them with a more intimate knowledge of FDA processes and procedures and valuable insight on FDA policies and personnel.

Unique among law firms, the Group is cross-linked with FLH's expertise in Hatch-Waxman litigation and product lifecycle management, including Paragraph IV Certifications and Notice Letters, bioequivalence and other requirements for 505(b)(2) NDAs and ANDAs, licensing and corporate transactions, and antitrust considerations. In this regard, the firm advises and represents both branded and generic drug manufacturers. We also draw upon FLH's scientific expertise in intellectual property matters, including a team of scientific advisors with Ph.D.s and other technical degrees.

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Leerink's Global Healthcare Conference 2014 in New York features include panel and keynote presentations on emerging healthcare trends
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BioCentury TV This Week features: The Battle Over Biosimilar Business Models
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FDA/Regulatory Group

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BioCentury TV This Week features FLH's Brian Malkin in The Battle OVer Biosimilar Business Models - with links to the interviews
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FTC Biosimilars (Follow-on Biologics) Workshop provides venue for discussion on state substitution/notification and naming proposals on competition
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Liquid dietary supplements and beverages distinguished in new FDA Guidance
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JAMA takes a look at FDA's approval of druga and medical devices: how much clinical data is required and is it consistent they ask
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