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Laura Sim is a special counsel in the firm’s Food & Drug Practice Group in the Washington, DC office. She advises drug, biologic, and food manufacturers and trade associations on a range of regulatory and consumer protection issues, with a focus on drug safety, biosimilar regulation, product life cycle management, and the intersection of the drug, medical device, and food industries with laws administered by the Consumer Product Safety Commission.
Representative Matters
- Developed legal strategies and researched and drafted citizen petitions to FDA on behalf of drug and food manufacturers.
- Drafted comments of trade associations and drug manufacturers on FDA proposed rules and draft guidances.
- Drafted Congressional and expert witness testimony concerning drug laws and drug safety.
- Analyzed, proposed amendments to, and drafted advocacy talking points concerning proposed drug safety and biosimilar legislation on behalf of industry.
- Advised drug and food manufacturers on compliance with evolving CPSC rules.
- Advised drug manufacturers that were the subject of government investigations into GMP and promotional practices.
Honors and Rankings
- H. Thomas Austern Memorial Award, Food and Drug Law Institute (2005)
Pro Bono
- Assists plaintiffs of a class action lawsuit against the District of Columbia to reform the District's juvenile justice system.
Publications and Speeches
- "Biosimilar Naming: How Do Adverse Event Reporting Data Support the Need for Distinct Nonproprietary Names for Biosimilars?," FDLI's Food & Drug Policy Forum (3/27/2013), Co-Author
- "The U.S. Biosimilar Pathway Nearly Three Years Later," GxP Lifeline (December 2012), Co-Author
- "Understanding the U.S. Biosimilar Pathway in 2012," FDA News Webinar (6/28/2012)
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