By working with clients to navigate the complex world of federal food and drug regulation, Anne Spiggle helps clients focus on their individual business objectives. Anne believes she can best enable clients to achieve their goals by taking a multi-faceted, “think-out-of-the-box” approach that considers the client’s needs from both regulatory and public policy angles. She has developed a broad range of regulatory experience, representing clients in connection with the development, promotion and sale of:
Prescription and over-the-counter drugs
Anne’s representation of clients includes significant experience on a wide range of regulatory and public policy matters involving the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC) and other federal and state health and safety regulatory agencies. This experience includes counseling clients on regulatory requirements, assisting clients in responding to regulatory enforcement actions, and helping clients engage in the regulatory process through preparation of regulatory submissions (such as Citizen Petitions, New Dietary Ingredient submissions and comments on agency rulemakings).
Articles in the National Law Review database by Anne Spiggle