PROFILE

Carolyne Hathaway retired from the partnership in November 2015. With the firm since 1987, Carolyne was a member of both the Environment, Land & Resources Department as well as the Corporate Department, and her practice focused on matters involving the Food and Drug Administration (FDA). In addition to her legal training and practice, Carolyne has a technical background in chemistry and the biological sciences, and an MBA in health care management. Carolyne 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 provided counseling to companies on issues of regulatory compliance and interpretation.  Carolyne also 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, Carolyne served as a judicial clerk to Judge J. Harvie Wilkinson, III of the United States Court of Appeals for the Fourth Circuit.

Carolyne's publications included:

• “FDA Announces Planned Changes to the 510(k) Premarket Notification Program,” Client Alert (December 2018) 
• “FDA Issues Draft Guidance on Biosimilar Interchangeability,” Client Alert (January 2017)
• “Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity,” Bloomberg BNA (August 2014)
• “FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices,” Client Alert (August 2014)
• “Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications,” Bloomberg BNA (April 2014)
• “A Look at the FDA’s New Social Media Guidance,” Client Alert (February 2014)
• “FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages,” Client Alert (February 2014)
• “The Regulation of Follow-on Biologics,” Client Alert (December 2013)
• “Preparing for a ‘New Era of Medical Product Development,'” Client Alert (November 2013)
• “POM Wonderful Opinion Provides Limited Clarification on FDC Substantiation Requirements,” Client Alert (October 2012)
• “Foreign Clinical Trials: FDA Issues New Guidance,” Client Alert (April 2012)
• “Opening the Door for Generic Biologics: FDA Releases the First Guidance Documents Implementing the Biosimilar Approval Pathway,” Bloomberg BNA (March 2012)