Posted: November 1st, 2022
I need a response for the following peers:
Fast Track is an initiative by an agency in the US known as Food and Drug Administration (FDA) to investigate drugs for expedited review to enable development of those that would cure acute diseases, as well as fill in the unmet gaps in the medicinal field. The process of approving a drug to be consumed by human beings takes up to twelve years in the prompt laboratory. Therefore, the FDA ensures that efficient processes during the development of Fast Track drugs are met based on the rules and regulations of the whole initiative. The medical conditions under which a patient is allowed to take such drugs are also critical and vital considerations.
In the case of the process of approving and expediting Fast Track drugs, different programs are put in place to review their purpose and efficiency in the subject. One of the major programs that are essential during the development of Fast Track drugs is conducting an in-depth study and understanding of the project so that it follows an effective path before approval (Kesselheim, Wang, Franklin, & Darrow, 2015).
Accelerated approvals may also be conducted upon agreement between drug sponsors and FDA. Some of the agreements that may be made before this type of approval are based on the unmet needs present to a demographic regarding the subject, surrogate endpoints that would be scrutinized, and the benefits that the drug would have to the patient population being studied, as well as post-marketing commitments.
Fast Track drug regulation starts by adopting and submitting it to the Town Hall website where the executive branch reviews it. Executive branch under the office of the Attorney general reviews the Fast Track before the Cabinet Secretary Governor submits it to the Town Hall. Emails are then sent to Townhall registered users before the review is published. This process takes place within ten days of review submission by the Cabinet Secretary Governor. After the publication, people are given a chance to comment before it is implemented. Any disapproval from one or more members of the standing committee of the Senate, house delegates, a member of the joint commission or ten people from the public cause the Fast Track regulation to serve as a Notice of Intended Regulatory Action. On the other hand, lack of disapproval from any of the titles mentioned above makes the regulation effective after fifteen days.
The use of Fast Track drugs is warranted under different conditions. One of the medical conditions that call for the use of such drugs is when there is a serious condition in a particular demographic (Hwang, Darrow & Kesselheim, 2017). Therefore, if there are any positive impacts of using a Fast Track drug, then the approval of administering the cure is given. The approval may be booked under two circumstances. One is the survival factor that the drug can offer while the other regards preventing the disease in the subject from worsening (Hwang et al., 2017). Similarly, a Fast Track drug may be warranted if there is an unmet medical need. Therefore, people are allowed to take such drugs if they treat them or prevent them from contracting a particular disease.
Fast Track drugs follow a strict path before being approved to be used. It is done to avoid any health risks that may befall the public by using them. Therefore, the FDA makes life-saving investigational drug therapies by offering expedited drug approval. The process is what is identified as Fast Track in the paper. These drugs pass through reviews before being accepted to be used by people want to manage or prevent a particular disease.
Above is the original work if needed:
The Food and Drug Administration (FDA) is a U.S. government agency within the Department of Health and Human Services. Its primary role is to protect public health, by ensuring safety and effectiveness of drugs, vaccines, medical devices and food products. There are rigorous steps that may take years, and all these steps must be completed before a drug can be approved. The FDA has made some lifesaving investigational drug therapies available sooner than usual by offering an expedited drug approval process, known as “Fast Track”.
I. Discuss the process and regulations of Fast Track.
II. Identify which medical conditions warrant the use of “Fast Track” drugs.
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