US FDA: Roles, Responsibilities and Guidance for Clinical Research

This report provides a comprehensive overview of the United States Food and Drug Administration (FDA), detailing its crucial roles and responsibilities in safeguarding public health. The FDA regulates a wide array of products, including drugs, medical devices, food, and tobacco, ensuring their safety, efficacy, and proper labeling. The report explains the Code of Federal Regulations (CFR), particularly Title 21, which governs food and drug regulations. Furthermore, it highlights specific FDA guidance documents related to clinical trials, emphasizing risk-based monitoring, the acceptance of foreign clinical studies, and the use of computerized systems. The report also covers ethical considerations for clinical trials involving children, providing a detailed understanding of the FDA's regulatory framework and its impact on the healthcare industry.

Running head: US FDA ROLES, RESPONSIBILITIES AND GUIDANCE
US FDA, ROLES, RESPONSIBILIES AND GUIDANCE
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1US FDA ROLES, RESPONSIBILITES AND GUIDANCE
Roles and Responsibilities
The Food and Drug Administration (FDA) of the United States, is an organization of the
government which plays a key role in the regulation of food and associated products like drugs,
nutritional supplements, and cosmetics, equipment used for medical equipment, biological items
and blood based products. The primary responsibility of the FDA is to ensure that the health of
the public is protected by conducting regulatory practices which ensure that drugs, for human
and veterinary purposes, along with medical equipment and biological items are safe, efficient
and secure (Zhou et al. 2018). An additional responsibility of the UD FDA is to ensure that the
nation is adequately supplied with essential food products, radiation producing items and
cosmetics, which are safe for usage and consumption by the citizens. In addition to the above,
the responsibility of the FDA is also associated with the regulation of the processes of
manufacture, marketing and distribution of tobacco and products containing tobacco along with
ensuring reductions in the usage of the same in the nation, especially among minor populations
(Downing et al. 2017). The FDA also has a salient responsibility in ensuring that optimum
standards of public health are met by regulating, guiding and establishing directives for
healthcare organizations to engage in manufacturing of healthcare products which are innovative,
efficient, safe and affordable. The FDA also engages in the provision of evidence based, high
quality scientific information to the public in the form of instructions for purchasing medicinal
items aimed at improvement and maintenance of public health. Lastly, the FDA is also
responsible for ensuring that the public is protected from threats to healthcare and safety,
especially in the face of crisis, by ensuring that adequate rates food supply in the nation are

2US FDA ROLES, RESPONSIBILITES AND GUIDANCE
maintained and that by ensuring the manufacturing of products which can protect the public from
harmful diseases (U.S. Food and Drug Administration 2019).
Code of Federal Regulations
The Code of Federal Regulations (CFR) comprise of a set of codes applied to rules and
regulations which are permanent as well as general, and are established by the United States
federal government’s executive agencies and departments, and is also known as the
administrative law. CFRs are categorized into a total of 50 titles – each of them representing a
subject or area of study regulated by the federal law (Naci, Smalley and Kesselheim 2017). Of
the 50 titles of CFR, Title 21 is the CFR which is responsible for the governance of drugs and
food products circulating within the United States, for associated organizations such as the
Office of National Drug Control Policy (ONDCP), the Drug Enforcement Administration (DEA)
and the Food and Drug Administration (FDA). The title is divided into three chapters, the first
chapter is associated with the FDA, the second chapter is associated with the DEA and the third
chapter is associated with the ONDCP (Ghazala 2016). The first chapter associated with the
FDA is based primarily on the Federal Food, Drug and Cosmetic Act and deals with regulation
of human participants within clinical trials and quality practices to be conducted in the
laboratory. The series of 100 is primarily concerned with food products such as regulation of
labelling of nutrition facts in food products, dietary supplements, trans fats, minerals and
vitamins. The series of 200 and 300 deal with pharmaceuticals especially marketing and
advertising and requirements of novel and over the counter drugs (Ma, Marinovic and Karaca-
Mandic 2015).

3US FDA ROLES, RESPONSIBILITES AND GUIDANCE
FDA Guidance
The US FDA provides multifaceted, comprehensive guidance for optimum, safe and
ethical conductance of clinical trials. A key aspect of guidance provided by the FDA for the
purpose of critically evaluating the validity of clinical trials is concerned with the utilization of a
risk based approach monitoring (RBM) framework. Considering the same, the US FDA instructs
sponsors of clinical trials that an RBM assessment plan consists of critically detecting the risks
associated in the concerned clinical trial which can hinder the collection of data and analytical
processes of data interpretation. The risk assessment must also follow an evaluation of the
possible shortcomings associated with the methodological quality of the trials (U.S. Food and
Drug Administration 2019). Similarly, concerning the guidance in terms of acceptance of clinical
studies which are foreign, the FDA denotes the acceptance of such a trial only if it observes the
study’s alignment with the ethical considerations postulated by the Declaration of Helsinki (U.S.
Food and Drug Administration 2001). Concerning the usage of computerized systems in clinical
trials, the US FDA’s guidance instructs that clinical trials must identify the usage of such a
system at every step of the study, the maintenance of standard operating procedures and the
availability of limited access to authorized personnel for ensuring participant privacy (U.S. Food
and Drug Administration 2007). For clinical trials wishing to recruit children as participants, the
FDA denotes that researchers must specify the justification to understand, prevent and alleviate a
detrimental health problem in children, comply with ethical principles and obtain parental
consent (U.S. Food and Drug Administration 2006).

4US FDA ROLES, RESPONSIBILITES AND GUIDANCE
References
Downing, N.S., Shah, N.D., Aminawung, J.A., Pease, A.M., Zeitoun, J.D., Krumholz, H.M. and
Ross, J.S., 2017. Postmarket safety events among novel therapeutics approved by the US Food
and Drug Administration between 2001 and 2010. Jama, 317(18), pp.1854-1863.
Ghazala, S., 2016. The CRC Master Keyword Guide for Food: 21 CFR Regulations of the Food
and Drug Administration. CRC Press.
Ma, P., Marinovic, I. and Karaca-Mandic, P., 2015. Drug manufacturers’ delayed disclosure of
serious and unexpected adverse events to the US Food and Drug Administration. JAMA internal
medicine, 175(9), pp.1565-1566.
Naci, H., Smalley, K.R. and Kesselheim, A.S., 2017. Characteristics of preapproval and
postapproval studies for drugs granted accelerated approval by the US Food and Drug
Administration. Jama, 318(7), pp.626-636.
U.S. Food and Drug Administration (2001). Acceptance of Foreign Clinical Studies. [online]
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-foreign-
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U.S. Food and Drug Administration (2007). Computerized Systems Used in Clinical Investigal
Investigations. [online] U.S. Food and Drug Administration. Available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-
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U.S. Food and Drug Administration (2019). A Risk-Based Approach to Monitoring of Clinical
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-based-
approach-monitoring-clinical-investigations-questions-and-answers [Accessed 3 Jun. 2019].
U.S. Food and Drug Administration (2019). What We Do. [online] U.S. Food and Drug
Administration. Available at: https://www.fda.gov/about-fda/what-we-do [Accessed 3 Jun.
2019].
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Sridhara, R., 2018. Overview of Oncology and Hematology Drug Approvals at US Food and
Drug Administration Between 2008 and 2016. JNCI: Journal of the National Cancer Institute.