Carolyne Hathaway is a partner in the Washington, D.C. office of Latham & Watkins. She is a member of both the Environment, Land and Resources Department as well as the Corporate Department, and her practice focuses on matters involving the Food and Drug Administration (FDA). In addition to her legal training and practice, Ms. Hathaway has a technical background in chemistry and the biological sciences, and an MBA in health care management. Ms. Hathaway has extensive experience in technical regulatory matters and has represented pharmaceutical, device, biotechnology, chemical and agrichemical companies at various stages of product development, including preclinical and clinical testing, regulatory approval and commercialization. She has participated in a variety of proceedings before FDA and Centers for Medicare & Medicaid Services (CMS), and has provided counseling to companies on issues of regulatory compliance and interpretation. Ms. Hathaway also has assisted clients participating in rulemaking proceedings relating to a variety of regulatory issues. She has worked with trade associations and industry consortia to address specific regulatory issues pertaining to various federal and state laws and initiatives.
Before entering private practice, Ms. Hathaway served as a judicial clerk to Judge J. Harvie Wilkinson, III of the United States Court of Appeals for the Fourth Circuit.
Ms. Hathaway's publications include:
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“The Changing Regulatory Landscape for In Vitro Diagnostic Medical Devices: Increased Scrutiny of Laboratory Developed Tests and the Safety of Personalized Medicine,” The Food and Drug Law Institute’s Update Magazine, September/October 2010
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“The Web of Clinical Trial Registration Obligations: Have Foreign Clinical Trials Been Caught?,” The Food and Drug Law Journal, June 2009
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“Exclusivity Strategies in the United States and European Union,” FDLI Update, May/June 2009
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“What to Think About When Considering an Overseas Clinical Trial Program,” BioWorld Perspectives, March 12, 2009
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“Are You Set for the TSCA Reset?,” Client Alert, February 17, 2009
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“Looking Abroad: Clinical Drug Trials,” The Food and Drug Law Journal, September 2008
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“Ask the Expert,” Devices & Diagnostics Letter, February 25, 2008
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“What You Don't Know Can Hurt You: Understanding the FDA's Foreign Inspection Program,” Medical Devices, Volume 14, Issue 25, February 4, 2008
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“Pharmaceutical Provisions of the FDA Amendments Act of 2007,” Pharmaceutical Law & Industry, Volume 5, No. 41, October 19, 2007
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“Medical Device Provisions of the FDA Amendments Act of 2007,” Medical Devices Law & Industry, Volume 1, No. 16, October 10, 2007
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“Merck v. Integra: Supreme Court Permits Use of Patented Compounds to Obtain Food and Drug Administration Approvals,” The Food and Drug Law Journal, April 2006
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“FDA guidance on early stage drug development,” The Daily Transcript, March 31, 2006
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“Increased Scrutiny of Investor Communications by Federal Regulators,” FDLI Update, Drugs & Biologics: Safety & Availability, January/February 2006
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“FDA-SEC Initiative May Signal Increased Scrutiny of Investor Communications,” Pharmaceutical Law & Industry, Volume 2, No. 11, March 12, 2004
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“Market Exclusivity Options Under the FFDCA: Strategic Opportunities for Innovators of Pharmaceutical Products,” Pharmaceutical Law & Industry, Volume 2, No. 7, February 13, 2004
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“How to Obtain Market Exclusivity,” Drug Discovery & Development, February 2004