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ICH Guidelines and FDA Regulations
One of the biggest challenges with drug regulations is the different standards which are utilized by numerous countries around the globe. This is problematic, as these disparities make it hard for manufacturers to follow certain protocol when researching, testing and introducing new drugs to the marketplace. As a result, ICH and FDA regulations are becoming streamlined to offer greater amounts of transparency. To fully understand the way that this is occurring requires examining ethical and regulatory requirements which must be accounted for in the design of a clinical research study. This will be accomplished by conducting a literature review of various sources. Together, these elements will illustrate how the two standards are becoming integrated to achieve these larger objectives. (Carson, 2007)
Carson, P. (2007). Good Clinical, Laboratory and Manufacturing Process. Cambridge: Cambridge University Press.
In 1996, the FDA and ICH guidelines were integrated together. The result is that during any kind of clinical trial, there are a series of ethical standards which must be followed. The most notable include: informed consent, review from an independent oversight board, documentation and conducting the trials using multiple subjects by measuring the dependent / independent variables....
In this source, Carson (2007) is showing that the design must allow participants to drop out and seek their consent at all time. Furthermore, the tests must not harm the individual or have any kind of adverse consequences. These protocols are working off the foundation that was established by the Helsinki Accords and the Nuremburg Codes. During any kind of clinical trials, these standards must be followed to ensure that the subjects are treated fairly and humanely. (Carson, 2007)
These insights are important, as they are showing how any clinical study must follow standard protocol. The most notable include: informed consent, review from an independent oversight board, documentation and conducting the trials using multiple subjects according to measuring the dependent / independent variables. This is used by both the ICH and FDA to illustrate how the two are becoming streamlined to improve ethical and regulatory standards.
Schnoll, L. (2008). The Regulatory Compliance Act. Chico, CA: Patton Professional
In spite of the overall amounts of integration, many FDA guidelines are lagging behind those of the ICH. This is occurring with the FDA placing more of focus on the ethical treatment of animals vs. human subjects (via the Animal Welfare Act). The result is that many guidelines are not binding. Instead,…
References
Carson, P. (2007). Good Clinical, Laboratory and Manufacturing Process. Cambridge: Cambridge University Press.
Schnoll, L. (2008). The Regulatory Compliance Act. Chico, CA: Patton Professional.
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