This quality assurance (QA) tool is designed to assist section 804 importation program (SIP) sponsors prepare proposals that fully comply with the requirements under the final […]

Section 804 of the Federal Food, Drug and Cosmetic Act allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the […]

FDA has developed a pathway under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows states and Indian tribes to import […]

For Immediate Release: January 05, 2024 Español Français  Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section […]

Date: January 28, 2026 Time: 8:00 a.m. – 9:30 a.m. ET Organized By: The Eco-NAMS webinar series is co-organized by the U.S. Food and Drug Administration, […]

FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library – now hundreds of our recordings are readily accessible. Bookmark and […]

CDER and CBER have collaborated with the European Medicines Agency (EMA) to develop 10 guiding principles that industry and product developers can consider when using artificial […]

Learn from the Source: These presentations deliver perspectives directly from CDER subject matter experts who shape the policies and procedures that impact your product development and […]

Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter[1], FDA is creating the Split Real Time Application Review (STAR) pilot program.   Overview FDA […]