Law360 | Alston & Bird Nabs Former FDA Associate Chief Counsel

Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.

Alston & Bird has formed a working group to advise clients on the business and legal implications of the COVID-19 coronavirus.

Cathy Burgess is quoted on the dramatic decline in the Food and Drug Administration’s foreign inspections amid COVID-19.

Cathy Burgess, partner in Alston & Bird’s Health Care Group and leader of the firm’s FDA Compliance & Enforcement Team, has been recognized by The National Law Journal in its third annual list of professionals identified as agents of change in health care and life sciences law.

Alston & Bird health care attorneys have authored several chapters in a new edition of a book aimed at helping the rapidly evolving pharmaceutical industry master the governing principles and compliance standards for Current Good Manufacturing Practices (CGMPs).