Center for Drug Evaluation and Research (CDER) Specific Questions
- Drug Marketing and Advertising -- A number of changes have been made in the past few years related to Drug Advertising, especially in the area of Direct-to-Consumer Advertising. How can CDER ensure that drug promotion is both balanced and non-misleading? How can we better assure that drug advertisements communicate appropriate messages?
- Inspections -- CDER's inspection program is designed to ensure a high-quality drug supply. Is CDER's current inspection program adequate to achieve this goal? How should CDER ensure the quality of drugs manufactured in foreign establishments? Please comment on the role of partnerships such as the European Union-United States Mutual Recognition Agreement (MRA).
- Drug Information -- CDER is an authoritative and independent source of drug information. How can we assure that health professionals and consumers get the information they need about drugs? What methods of communication would be most effective in getting additional information about drugs to health professionals and consumers?
- Surveillance and Adverse Event Reporting -- Adverse events thought to be associated with medicines were recently reported to be the sixth largest cause of death in the United States. CDER has recently modernized its reporting system. What else needs to be done to detect, analyze, communicate, and respond to the causes of death and injury from medicines?
- Balance -- How should CDER balance the need for strong and timely premarket review programs with the need for effective postmarket inspection, surveillance and enforcement programs?
- Priorities -- What should be CDER's highest priorities for action? What changes at CDER would have the most beneficial effect for the American people?
FDA Plan for Statutory Compliance