Prepare a report (formatting specifications below) outlining the 2020 COVID-19 drug authorization process a Canadian manufacturer of COVID-19 drugs and vaccines could use, as well as the necessary regulatory submission to maintain market authorization. The report should include, but is not limited to the following elements: Purpose/objective/overview of the temporary (interim) authorization pathway. Description of: key elements that were introduced in the temporary authorization pathway to increase authorization efficiency (describe at least 3) the regulatory submission requirements the same manufacturer must fulfill to maintain market authorization following expiration of the interim authorization. Detailed critical analysis of 2 new elements introduced in the temporary authorization pathway. You may select any 2 new elements found in the temporary authorization pathway. Your analysis should indicate the advantages of disadvantages of these two components. The critical analysis should focus on safety and efficacy requirements established in division 8 of the FDR.

Prepare a report (formatting specifications below) outlining the 2020 COVID-19 drug authorization process a Canadian manufacturer of COVID-19 drugs and vaccines could use, as well as the necessary regulatory submission to maintain market authorization. The report should include, but is not limited to the following elements: Purpose/objective/overview of the temporary (interim) authorization pathway. Description of: key elements that were introduced in the temporary authorization pathway to increase authorization efficiency (describe at least 3) the regulatory submission requirements the same manufacturer must fulfill to maintain market authorization following expiration of the interim authorization. Detailed critical analysis of 2 new elements introduced in the temporary authorization pathway. You may select any 2 new elements found in the temporary authorization pathway. Your analysis should indicate the advantages of disadvantages of these two components. The critical analysis should focus on safety and efficacy requirements established in division 8 of the FDR.

Chemistry

10th Edition

ISBN:9781305957404

Author:Steven S. Zumdahl, Susan A. Zumdahl, Donald J. DeCoste

Publisher:Steven S. Zumdahl, Susan A. Zumdahl, Donald J. DeCoste

Chapter1: Chemical Foundations

Section: Chapter Questions

Problem 1RQ: Define and explain the differences between the following terms. a. law and theory b. theory and...

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