sihamak

According to the textbook, all of the following statements regarding the use of a reimbursement dossier in the US are true except:

a. Its development should be initiated after a regulatory submission has been made and the company is awaiting a decision from the FDA

b. It includes information about the product, key clinical studies and results, economic evaluation of data, modeling reports, and an overall assessment of product value and cost

c. It is typically distributed to payers just after final labeling becomes available from the FDA

d. It anticipates and addresses the information requirements of payers’ technology assessment organizations

What are the main issues when it comes to pattern-based evidence? 

Explain how a drug that inhibits the action potential, a sedative drug, does so. (1 mark)