Develop a REMS (Risk Evaluation and Mitigation Strategy). for a new pain medication which is a controlled substance (CII).
make sure that the benefits of the drug outweigh the risks of abuse and misuse. Include how would you launch the program into the marketplace.
500 words no plagiarism please
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Develop a REMS (Risk Evaluation and Mitigation Strategy). for a new pain medication which is a controlled...
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 500 words summary of the elements that you would include and how would you launch the program into the marketplace. No...
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