What is high level submission process of submitting rmp

Assignment Help Other Subject

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:

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

Reference no: EM133494352

Questions Cloud

Determining the meaning of a work of art : Who is responsible for determining the meaning of a work of art? The artist or the viewer? Why?

Interventions and rationales for occupational therapy : What are the nursing interventions pre, intra and post occupational therapy and What are the overall nursing interventions and rationales for occupational

Discuss the role of male-female power struggles : Is it important to consider the role of male-female power struggles when studying a work? Why or why not?

Summary of the magnet status model components and diverse : Summary of the Magnet status model components and diverse data elements that can be used in the hospital's Quality Improvement initiatives that will be measured

What is high level submission process of submitting rmp : Is REMS required by both brand name and generic manufacturers? If so, what are the differences between both types of REMS? What is high level submission process

How can a company keep from sliding into the decline stage : ???When should a person from outside the company be hired to manage the company or one of its units? ???How can corporate culture be changed? How can a company

Why do you think in this pivotal moment he acts quickly : Why do you think in this pivotal moment he acts quickly, without the hesitation that has otherwise plagued him?

Explain why are they important to you : If you had access to a PHR, what two pieces of information would be interesting for you to see, and fully explain why are they important to you

Responsibilities of a teacher and school support officer : Discuss the difference in the roles and responsibilities of a teacher and school support officer?

User Account

All Pages