case study

Please read the following case study (and questions) carefully. Identify the key words in the case study and perform a literature review using these key words. Provide a reference list with the references you identified from your literature search (please provide them in APA format).

After you identify your reference list, use these references to answer the case study question listed below. You will need to submit your responses to this case study along with your reference sheet for grading. The case study should answer all questions and should be around 500-1000 words (excluding references, tables/figures/diagrams).

Case Study:

Priftin Rifapentine is a drug listed under The Access to Drugs in Exceptional Circumstances regulatory pathway in Canada. This pathway enables access to drugs which have been authorized for sale in certain foreign jurisdictions, but are not available in Canada, to address urgent public health needs.

Please answer the following questions:

1. Explain Access to Drugs in Exceptional Circumstances pathway, and Priftin Rifapentine drug listed under this pathway.
2. What are the roles and responsibilities of Health Canada and Public Health Officials?
3. How are drugs added and removed from the list using this regulatory pathway?
4. How do requirements for drugs subject to these Regulations differ from other federal regulatory requirements applied to drugs in Canada?
5. What requirements, under the FDR, must be met to import a drug on the List?