Part 5
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Question 1. The process used for approving the drug that is supposed to be taken by human being takes up to 13 years. Therefore, FDA makes sure that there is an effective process in the courses of developing fast-track drugs based on the rules as well as regulation of the entire process (Hwang, Darrow, & Kesselheim, 2017). The condition under which the individual is required to use a fast track drug is a special consideration before the warranty is given to use them. In order to approve the fast track drug, various programs are implemented to review the efficiency and subject of the drug. The m most crucial program has to do with researching to understand the project so that the approval can go on. Accelerated approval is also conducted after an agreement among FDA and the sponsors. The process takes place in ten days. Immediately after publication people are allowed to give their views on the same before implementation. Disapproval from members of the standing committee of the senate, member of the joint commission, ten members or more from public and house delegate will make fast track revulsion serve as the notice of intended regulatory action. Contrarily lack of disapproval from any of the above-mentioned members will permit the effectiveness of regulation after 15 days (Goldberg et al. 2018).
Question 2. The application of fast track drugs is allowed under various conditions. The primary reassigns that may require the use of fast track dug is if there is a severe medical condition within a specific demographic population (Chambers et al. 2017). Furthermore, if there is a significant effect of using fast track drugs, it will result in the approval of administrating the cure. The approval may be founded on two situations; the survival factor the medicine will provide while the other reason is, the drug can prevent the disease from worsening. Additionally, the fast track drug might be warranted if there is a gap of unmet health needs. Thus, individuals will be allowed to use fast track drugs if it will prevent them from contacting or treating a certain disease.
References
Chambers, J. D., Thorat, T., Wilkinson, C. L., & Neumann, P. J. (2017). Drugs cleared through the FDA’s expedited review offer greater gains than drugs approved by the conventional process. Health Affairs, 36(8), 1408-1415.
Goldberg, K. B., Blumenthal, G. M., McKee, A. E., & Pazdur, R. (2018). The FDA oncology center of excellence and precision medicine. Experimental Biology and Medicine, 243(3), 308-312.
Hwang, T. J., Darrow, J. J., & Kesselheim, A. S. (2017). The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016. Jama, 318(21), 2137-2138.