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What is high level submission process of submitting rmp

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Reference no: EM133494352

Case: A REMS, which may be a medication guide, a patient package insert, and/or a communication plan is a required risk management strategy to help FDA ensure that the benefits of a drug outweigh the risks.

FDA may require a more stringent version of a REMS, with elements to assure safe use (ETASU), which can include, for example, requirements that prescribers have particular training or experience, that patients using the drug are monitored, or that the drug be dispensed to patients with evidence or other documentation of safe use conditions.

Explanations:

  1. Why sponsor need to consider about REMS before marketing application?
  2. What are the major elements of REMS that sponsors must include in REMS assessment?
  3. Is REMS required by both brand name and generic manufacturers? If so, what are the differences between both types of REMS?
  4. What is high level submission process of submitting RMP in Europe?

Reference no: EM133494352

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