<unk>  <unk>  is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects.<unk>  applies only to specific prescription drugs, but can apply to brand name or generic drugs. The<unk>  program was formalized in 2007. The FDA determines as part of the drug approvals process that a<unk>  is necessary, and the drug company develops and maintains the individual program.<unk>  applies only to specific prescription drugs, but can apply to brand name or generic drugs.<unk>  for generic drugs may be created in collaboration with the manufacture of the brand name drug. The FDA may remove the<unk>  requirement if it is found to not improve patient safety. The<unk>  program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, and Thalidomide, which is used to treat leprosy but causes serious birth defects. The 2007 Food and Drug Administration Amendments Act created section 505-1 of the Food, Drug, and Cosmetic Act which allowed for the creation of the<unk>  program for applying individual monitoring restrictions to medications. Some of the provisions required by the<unk>  program are training and certification of physicians allowed to prescribe the drug, requiring that the drug be administered in a hospital setting, requiring pharmacies to verify the status of patients receiving<unk>  drugs, requiring lab testing of patients to ensure that health status is satisfactory, or requiring that patients be entered into a registry.
Risk Evaluation and Mitigation Strategies
Source control 
Pharmacy research
Guidances for statistics in regulatory affairs
Operational Research CONsultancy
Clinical governance
Collaborative practice agreement
Priority review