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        Guidance, Compliance, & Regulatory Information

Surveillance: Post Drug-Approval Activities

                        
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          Surveillance: Post Drug-Approval ActivitiesGuidance, Compliance, & Regulatory Information Surveillance: Post Drug-Approval Activities
  	
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    PrintA vital part of CDER's mission is to monitor the safety and effectiveness of drugs that are currently available to the American people.  To meet this goal, FDA has in place postmarketing programs that monitor marketed human medical products for unexpected adverse events. These programs alert the Agency to potential threats to the public health.  Agency experts then identify the need for preventive actions, such as changes in product labeling information and, rarely, re-evaluation of an approval decision.

                                                                                  Content current as of:
      02/05/2018Surveillance: Post Drug-Approval Activities                
                          

                        Report a Product Quality Issue


                        Office of Prescription Drug Promotion
          Prescription Drug Advertising and Promotional Labeling
          Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
 
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