CLINICAL RESEARCH
2
operating procedures (SOPs), and even the study director has been unable to assure that the
data obtained are accurate and are correctly verified (Oeyama-Moto-Medical Group
Foundation, LLC - 552421 - 05/21/2018, 2020). The testing facility for Oeyama-Moto
Medical Group Foundation did not give any confirmed data that explains documentation,
protocols, final reports, specimens and raw data. FDA assured that without any proper
assurance, there would not be any promotion for the experimental proceedings.
FDA also generated a warning letter to Dr Khan explaining that the documents
submitted by him are lacking statutory requirements as well as the FDA rules. It failed to
retain the data that would help in the approval of the drug to be marketed. Failure in getting
permission for drug approval would stop the medicine from getting marketing approval.
Regulations that were violated
Violation of laws would create a bigger problem for Sohail M khan as well as for the
Oeyama-moto medical group foundation. A set of laws were violated by both of them. The
rules that were broken as per the warning papers are as follows-
In the Oeyama-moto medical group foundation a set of rules were violated. The
testing facility of this organisation did not assure the presence of QAU that is responsible for
the monitoring of the examination and it is different from the personnel engaged contact
studies. QAU provides unbiased and objective analysis study for approved and standard
protocol. They even failed to obey GLP requirement (Oeyama-Moto-Medical Group
Foundation, LLC - 552421 - 05/21/2018, 2020). Precisely, the organisation did not give any
records for quality assurance activities.
Nevertheless, the function of QAU needs separate functioning and independent
policies conducted in the nonclinical laboratory study. The organisation even did not give any
record for standard operating policies (SOP) for establishing nonclinical practices such as

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