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CDER Initiatives

the New Drugs Regulatory Program (NDRP) modernization effort allows CDER support staff in protecting and promoting health by ensuring drugs are safe, effective, and meet quality standards.

The Safe Use Initiative is designed to combat medication misuse and errors through the development of interventions that measurably reduce preventable harm from medications.

These networks foster collaboration across government, academia, industry, and advocacy groups. This collaboration aims to develop new tools and approaches to streamline regulated product development.

The Bad Ad Program is an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion by raising awareness across all healthcare professions.

The Marketed Unapproved Drugs guidance clarifies illegal marketing requires safety and efficacy applications, aligning with their broader effort to provide drug safety information for informed decisions.

This is a state-of-the-art electronic drug safety surveillance system that allows the FDA to monitor the safety of drugs once they are on the market and identify any potential safety concerns.

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