Clinical Research Essay: NDA Regulations and FDA Violations Analysis

This essay examines FDA regulations, focusing on the New Drug Application (NDA) process and the Investigational New Drug (IND) application. It analyzes inspection findings from the FDA, highlighting violations of Good Practices (GxP) guidelines and regulations by the Oeyama-Moto Medical Group Foundation and Dr. Sohail M. Khan. The essay details specific violations, including failures in Quality Assurance Unit (QAU) implementation, lack of Standard Operating Procedures (SOPs), data integrity issues, and record-keeping deficiencies. The impact of these violations on drug approval and the consequences for the involved parties are discussed. The essay concludes with suggestions for avoiding such problems, emphasizing the importance of a strong compliance culture and proper laboratory management. The document also provides an overview of how the violations affect the economic and promotional values of the organization.

Running head: CLINICAL RESEARCH
ESSAY ON NDA REGULATIONS
Name of the Student
Name of the University
Author note

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Introduction
GxP is considered to be the collection of guidelines that includes a decent quality of
rules as well as regulations. It is created to ensure that pharmaceuticals products need to be
safe by adhering to process the quality with appropriate control and storage mechanism. The
pharmaceutical product also needs to be safe for distribution and manufacture and thereby
meeting the intended usage. The NDA (New Drug Application) application is considered the
medium by which drug is sponsored and FDA (Food and drug administration) approves the
sale for new pharmaceutical and marketing of the drug in the USA (Bablani & Janodia,
2019). The data collected during human and animal studies undergo clinical trials for further
investigation by IND (Investigational New Drug) and then it becomes part of NDA.
Investigational New Drug (IND) claim is mandatory as the main idea of clinical research
learning is to progress material that recommends the usage or appraisal for the protection and
efficiency of an unapproved drug. The primary purpose of this essay is to explain the process
that requires necessary measures so that the FDA finds the new drug products ready for
approval. It is structured to discuss the contamination occurred during an inspection of FDA,
rules that were violated, the impact of the violation on the products and the list of suggestions
for solving the problem.
Key problem
Violations discovered by the FDA
After an investigation from the FDA, it was discovered that Oeyama-Moto Medical
Group Foundation violated some rules in the clinical practices. They failed to follow the
appropriate statutory rations and regulations that are designed by the FDA for governing and
conducting nonclinical studies. The organisation was unable to guarantee that there was
Quality Assurance Unit (QAU), it also failed to promote any established output for standard

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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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preparation in animal room, storage, identification and mixing. As there is no SOP provided
FDA can conclude that the approaches trailed at the examination facility for animal care as
well as for nonclinical toxicity study were ineffective or inadequate towards integrity and
quality.
The foundation did not provide any experimental data for the toxicity study that were
conducted in the year 2008. Toxicity study requires dose analysis and weight measurement of
the body, and it is necessary to maintain the record. Even there was a violation of the
purchase record and data that was entered in 2016 was found invalid. The foundation also
violated the rules that were towards the specimen. It did not give any data that was requested
as per the provisions of investigation. This is considered to be a complete violation of the
law. There was also no designated space for specimen and storage. Hence, the inspection
output resulted in substantial apprehensions about the truthfulness of the records and data.
Every animal has a particular level of solution intake; however, the foundation violated in
solution component concentration (Oeyama-Moto-Medical Group Foundation, LLC - 552421
- 05/21/2018, 2020). The stability of the mixture was a big issue, and hence it is a complete
violation of the law.
On the other hand, the protocol needs to have a proper date of entry record. FDA
inspection showed that the data presented by foundation do not have any recorded date of
entry. Hence, there is a violation of the law. Lack of information was found in various
aspects, and therefore it needs to be fixed.
In the case of Sohail M Khan, a warning letter was generated as there was also a
violation of laws. He was a clinical investigator; however, there was no retained recorded
data for the disposition of the drugs, including quantity, dates and retained adequate. There
was a mistake in precise histories for all the examination output and other pertinent towards

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the individual administered drugs. The retention of the records is necessary, and the data was
absent; therefore it is considered as the violation of the laws and regulations (Sohail M. Khan,
M.D. - 539274 - 10/10/2017, 2020). The records of the data are necessary for a marketing
application for drugs and hence violating the law would prevent drug marketing. He also
violated rules by not keeping any record of the protocols of the last two years that showed
approvals and indication of the test study. Sohail Khan violated the law by not maintaining
any proper documentation, which is essential for marketing as well as per testing purposes.
Impact of violation
Oeyama-moto medical group foundation violated GLP requirements; hence it would
prevent QAU from performing necessary actions of confirming that methods, practices,
facilities and records are in conformance. Violation of the law would prevent the facility from
establishing standard operating procedures hence affecting feeding, handling, housing and
animal care. It would prevent them from animal handling. Violation of the law would
develop some negative impact on future regulatory activities such as approvals (Limbu,
McKinley & Temperini, 2019). As there was a violation in presenting recorded data and there
was no documentation for that FDA can question the integrity of the foundation and hence
challenge the reliability of the specimen and facility data that were provided beforehand.
Violation of law affected testing facility as there was a limited number of the animal
specimen and tissues blocks (Oeyama-Moto-Medical Group Foundation, LLC - 552421 -
05/21/2018, 2020). The raw experiment data was lost from the hamster study. As the
foundation violated the law. FDA is anxious about the consistency of the mixtures, the
concentration of the test objects in the mixtures as well as the constancy of the test and
control objects in the mixtures are used in the nonclinical toxicity examination conducted
(Limbu, McKinley & Temperini, 2019). Hence, the FDA disapproved the quality and
consistency of the test data. FDA’s examination findings failed to accomplish the primary

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duties in establish apposite guidelines and procedures that are proposed to safeguard the
integrity and quality of nonclinical data for FDA. Additionally, the inefficiencies from the
director and the nonappearance of an independent QAU specified that the testing facility
failed in maintaining the core duties to endure GLP compliant. Hence, FDA is doubtful
about the rationality of nonclinical data produced by the testing facility.
Dr. Sohail Khan failed to maintain study records that are necessary for FDA
regulations and thereby questioning the legitimacy and integrity of data
significantly. Violation of law towards drug liability records and case antiquities for both
studies, generated data that are unreliable and hence the facility support for marketing
application would not be reliable as per FDA investigation (Sohail M. Khan, M.D. - 539274 -
10/10/2017, 2020). The violation and letter generation would affect the production facility as
well as the inspected product. The laboratory would face restrictions for using the facilities.
As there are quality assurance issues, the company cannot use the product for further
purposes.
Suggestions for avoiding the problems
There is a different way used in escaping problems are by developing active company
obedience culture and conveying defiance message to the employees. It is essential by the
organisation and individual to have accurate reflection by safeguarding problems that require
serious attention and communicated for writing (Lewis, Jackson & Bailey, 2019). The
clinical lab authority and marketing personnel need to be involved in professional
development by having a subsequent communication with the laboratory personnel. Timely
resolutions of problems specify complete remedial activities and timelines engagements in
process. Some issues also include reoccurring enlightenments of the identical problem,
assured accomplishment, functioning with an absence of control and history acquisition. It

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highly recommended that administration of the company to have a proper proctoring of all
the laboratory works that are being conducted with appropriate maintenance of laboratory
ethics.
Conclusion
It can be concluded from the above essay that the generation of a warning letter is not
suitable for the organisation's reputation. FDA generates warning letter when the organisation
or the marketing individual does not follow the rules and the guidelines that are set by the
FDA correctly. Hence, it is highly recommended to follow the rules and regulation that are
structured by the FDA. Diversion from the rules that are set by would create a negative
impression for the company. It would affect the economic progression of the company.
A better understanding of the precise evidence used to substantiate economic claims
might provide insights into problematic applications. It helps to understand that violation of
FDA rules can reduce the commercial applications that are developed by marketing
departments, outcomes research departments, or jointly.
Research has shown that further analysis of this avoidance of FDA generated warning
letter affects economic and promotional values of the organisation, thereby affecting the
regulation of the company policies.

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References
Bablani, S., & Janodia, M. D. (2019). Analysis of FDA Warning Letters Issued to Indian
Pharmaceutical and Medical Device Companies: A Retrospective Study. Therapeutic
innovation & regulatory science, 2168479019879380
Limbu, Y. B., McKinley, C., & Temperini, V. (2019). A Longitudinal Examination of FDA
Warning and Untitled Letters Issued to Pharmaceutical Companies for Violations in
Drug Promotion Standards. Journal of Consumer Affairs, 53(1), 3-23.
Lewis, C. A., Jackson, M. C., & Bailey, J. R. (2019). Understanding medical foods under
FDA regulations. In Nutraceutical and Functional Food Regulations in the United
States and Around the World (pp. 203-213). Academic Press.
Sohail M. Khan, M.D. - 539274 - 10/10/2017. (2020). Retrieved 6 March 2020, from
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/warning-letters/sohail-m-khan-md-539274-10102017
Oeyama-Moto-Medical Group Foundation, LLC - 552421 - 05/21/2018. (2020). Retrieved 6
March 2020, from https://www.fda.gov/inspections-compliance-enforcement-and-
criminal-investigations/warning-letters/oeyama-moto-medical-group-foundation-llc-
552421-05212018