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1) What is the eCTD format? Briefly explain its importance to the global regulatory affairs profession for marketing approval of new pharmaceuticals(medicines) and biologic (biotechnology) products

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1) What is the eCTD format? Briefly explain its importance to the global regulatory affairs profession for marketing approval of new pharmaceuticals(medicines) and biologic (biotechnology) products.

2.Briefly describe one difference between the way the US FDA regulates cannabis and the way Health Canada regulates the use of cannabis products in Canada.

3.What is Real World Evidence(RWE), and why is this type of evidence increasingly becoming a critical component of FDA's evaluation of a biomedical product's performance from a clinical perspective?

4.Who is the current commissioner of FDA(Name)? Briefly describe one significant modification that this individual has announced or implemented to FDA regulatory process during this year.

5.How does US FDA regulates products containing cannabidiol(CBD)?

6.Please briefly describe the importance of the Bioligics Price Competition and Innovation Act Passed by the US congress in 2010 to biosimilar manufacturers.

Essay Questions

1.As we discussed in Module 3. there are conflicting opinions regarding the historical effectiveness of FDA’s reguLatory Pathway for manufacturers to obtain marketing approval for new biosimilar therapeutic products. In 2-3 paragraphs please explain your own opinion as to why FDA’s marketing approval process for new biosimilar products Is or Is not effective? As part of your answer please include an assessment of regulatory and other types of variables that both proponents, as well as opponents, of the process have used to describe their own opinion. Should FDA’s biosimiLar therapeutic marketing evaluation process remain the same, or do you believe it should be modified in some way?

2.Do you believe it is possible for FDA to accelerate its current new pharmaceutical and/or biologic approval process without compromising patient safety? If so, how can this be done? If not, Why?