Marc Scheineson, partner and leader of Alston & Bird's Food, Drug & Device/FDA Group, has authored a chapter for Food and Drug Regulation in an Era of Globalized Markets.
The book explores the various regulatory challenges that impact international markets and offers recommendations regarding the implementation of new regulations to ensure compliance.
Scheineson’s chapter, “FDA’s Global Investigation and
Enforcement Authority, Partnerships, and Priorities” (pages 15-24), offers a
comprehensive overview of the U.S. Food and Drug Administration’s manufacturing
standards and regulatory requirements for products marketed and sold within the
United States. The chapter focuses primarily on prescription drugs, as these
products are the most heavily regulated among the health care products that are
regulated by the FDA.