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Hoshyaran Jolodar H, Hadavand M, Abdollahiasl A. The Application of FDA Functional Models in the FDA Regulatory System of Iran with Emphasis on Informal Guidelines. MLJ 2020; 14 (55) :363-395
URL: http://ijmedicallaw.ir/article-1-1270-en.html

Background and aim: Regulatory governments need, above all, efficient and effective tools to play their role in regulating economic and social relations. Informal guidelines are among the tools that the U.S.A Food and Drug Administration (FDA) uses to guide actors in this industry as its primary method of policymaking as opposed on more formalized procedures. These methods can be used to explain the regulatory system of other governments.
Method: This research is of theoretical type and the research method is descriptive-analytical and the method of data collection is library and has been done by referring to documents, books and articles.
Results: Following improvements to the FDA regulatory system, this article discusses how and why the FDA's use of informal guidance to fulfill its statutory mandate has changed over the past century and introduces its valuable indicators to our country's regulatory system. Undoubtedly, with the help of the successful experiences of other leading countries in the field of regulation, the possibility of success in this complex field can be increased.
Ethical Considerations: In order to organize this research, while observing the authenticity of the texts, honesty and fidelity have been observed.
Conclusion: Undertake a normative analysis of the FDA's increasing reliance on informal guidance, this development has benefited the FDA's major stakeholders: (regulated entities, the public and the administration itself) and Considering to the existing legal contexts in the regulatory system of the Food and Drug Administration of Iran, this can be a normative localization in the legal system of our country.

Please cite this article as: Hoshyaran Jolodar H, Hadavand M. The Application of FDA Functional Models in the FDA Regulatory System of Iran with Emphasis on Informal Guidelines. Iran J Med Law 2021; 14(55): 363-395.