Clinical Research        2
CLINICAL RESEARCH
Table of Contents
Regulations of FDA    3
FDA Regulations in Research Environment    5
References    7
Regulations of FDA
    The Center for Drug Evaluation and Research (CDER) of FDA is mainly functional for the purpose of assuring that the American citizens gain access to safe as well as effective drugs (U.S. Food & Drug, 2020). However, the term ‘safe’ does not signify that the particular drugs are incapable of leading to different side effects. The term simply signifies that the potential benefits of the drugs outweigh the risks and negative impacts or the side effects of the same. The researchers and developers of drugs such as for instance, the different drug companies as well as the government agencies (for example, National Cancer Institute) need to seek permission as well as regulatory approval from Food and Drug Administration (FDA). FDA takes the responsibility of testing the drugs in humans, thereby making it available to the general populace.
    According to the law of the United States, it is mandatory for FDA to review all the results that are derived from the tests of the different kinds of new treatments to make sure that the new products are both safe as well as effective for the purpose of specific use (Zettler, Riley & Kesselheim, 2018). The initial research study begins with preliminary research and animal testing. However, there is a significant gap between the volume of compounds screened and the number of drugs receiving FDA approval. For instance, even if 50000 to 5 million compounds are screened, only one thousand will be considered to be worth pursuing (cisn, 2017). In addition to that, out of the thousand compounds, only 10 will be considered fit for clinical trial (cisn, 2017). Again, one out of the ten drugs will be considered to have adequate safety as well as efficacy to receive the approval of FDA (cisn, 2017). Therefore, from the above funneling of data into numbers it is clear that there is a significant depth in the regulations formulated by FDA.
    The regulatory process of FDA is extremely dense as well as holistic in nature. There are certain steps associated with the regulatory process of FDA. There is a need to submit an application prior to a clinical test as well as an application after the completion of a clinical test. In addition to that, there are different types of FDA review processes. There are two types of applications prior to a clinical test, they are called Investigational New Drug Application and Group C Drugs, also known as Treatment INDs. In case of Investigational New Drug, the potential drug exhibits promising results in the lab tests. Therefore, the drug company or the sponsor sends an application...