Tag Archives: Food and Drug Administration

FDA Issues Final Guidance on Proprietary Names for Drugs and Biological Products

Dozens of prescription medicine bottles in a jumble. This collection of pill bottles is symbolic of the many medications senior adults and chronically ill people take.

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