Tag Archives: Food and Drug Administration

We just got back from the Association of National Advertising (ANA) and Brand Activation Association (BAA) Marketing Law Conference in Chicago, held earlier this week.  With hundreds in attendance, and dozens of speakers presenting over three days, it was a great opportunity to learn about “hot” trends and key issues in the advertising and marketing space from an array of stakeholders – marketers, attorneys, regulators,… More

Naming pharmaceutical and biologic products presents unique challenges from both trademark and regulatory perspectives. In addition to the traditional marketing goals of trademark selection, companies evaluating names for medications must also consider safety issues, false advertising concerns, and more. Importantly, pharmaceutical trademarks must pass muster not only with the Patent and Trademark Office (PTO), but also with the Food and Drug Administration (FDA). The recent advent of a market for biosimilars presents new questions and challenges.… More

The Food and Drug Administration (FDA) has finalized guidance for industry describing the agency’s evaluation process for proposed proprietary names for drug and biological products.  The guidance applies to all prescription and nonprescription drug products, innovator and generic drug products, and biological products.  Drug products that may be legally marketed without an approved application are excluded (e.g., OTC drugs legally marketed under a tentative or final monograph). … More