The FDA's Center for Drug Evaluation and Research (CDER) ensures drug security by preventing counterfeit drugs, maintaining supply chain integrity, managing drug shortages, and preparing for public health threats, among other things. CDER collaborates with regulatory and law enforcement agencies to enforce regulations, monitors manufacturing and distribution practices, addresses potential drug shortages, and maintains robust post-market surveillance to address adverse drug events promptly. FDA’s CDER ensures the drug supply chain remains safe, secure, and reliable for public health. Hear directly from the agency about recent and ongoing expectations for entities involved in the drug supply chain, from pharmacies to distributors to manufacturers.
Learning Objectives:
Receive the latest updates in implementation of the Drug Supply Chain Security Act (DSCSA).
Learn about FDA’s efforts to combat counterfeit drugs from entering the supply chain, including forging relationships with international and domestic organizations.
Hear about CDER’s Office of Drug Security, Integrity and Response’s most recent regulatory and enforcement actions including warning letters against online entities selling unapproved and misbranded drugs.
Understand FDA authority to authorize state importation programs under section 804 of the Federal Food Drug and Cosmetics Act and the authorization of Florida’s state importation program in 2024.
