| Please conduct a literature search on the new FDA regulations dealing with REMS (Risk Evaluation and Mitigation Strategy). Scenario: You are the makers of a new pain medication (Relaxicam) which is a controlled substance (CII). The FDA has asked you to develop a REMS program to assure the benefits of the drug outweigh the risks of abuse and misuse. Write a 1 page summary of the elements that you would include and how would you launch the program into the marketplace. Please follow above instruction and cite |
