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Breaking Down the FDA Approval Process

Recent years have seen an increasing focus on FDA approval. One such example was the effort to test and make available the various COVID-19 vaccines promptly.

Those within the healthcare industry go through a process of developing and approving specific drugs that have the potential to help improve the lives of the communities they serve. While the COVID-19 vaccine development had urgency, the process is still thorough and fully regulated.

According to the FDA, “the approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.”

The approval process involves steps that resemble checks and balances for medical professionals. In addition, “there are three primary phases of the approval process: pre-clinical trials, clinical trials and new drug application review.”

Pre-clinical trials typically involve testing on non-human mammals. Upon completing this phase, professionals may move toward clinical trials that test human subjects willing to participate. There are usually different categories of clinical trials, involving specific stages along with certain numbers of volunteers.

If the clinical trial’s outcome is favorable, they will move toward a new drug application review. This step is the final phase of the process. Officials examine all the findings and determine whether the drug can carry out labeling and manufacturing inspections.

Upon reaching this stage, an additional phase may be forthcoming to test the ratings and usage after the drug is available to the public.

Health and Safety in the Medical Marketplace

When focusing on the approval process through a lens of health and safety in the medical marketplace, it becomes apparent it is more structured than most individuals would think.

The FDA states that “the drug approval process takes place within a structured framework that includes analysis of the target condition and available treatments, assessment of benefits and risks from clinical data and strategies for managing risks.”

Sometimes, it can be difficult for healthcare informatics professionals to determine the outcome of the benefits and risks associated with a particular drug. When this occurs, they must make the best judgment possible regarding the development of the drug. This process ensures they examine all data, as well as the results from multiple trials.

If the adverse effects outweigh the positives, professionals will shut down the drug’s distribution within the marketplace, which allows the health and safety of the medical field to prevail.

The Role of Data Analytics

Data analytics plays a vital role in determining the overall approval process because it derives from numbers and information collected by professionals. Therefore, everything that takes place within a trial should be documented and accurately labeled in order to truthfully provide results to the medical marketplace.

Each phase or trial involved in the approval process has its own data corresponding to the drug. If multiple trials are left out from this information, it can cause problems in the future that may harm citizens upon distribution.

Prepare to Approve With a Master’s Degree

One way to prepare to approve for the FDA is to further your career and earn your Master of Science (M.S.) degree. Those who enroll in the M.S. Healthcare Informatics online program at the University of Illinois Springfield will learn how to share accurate medical information quickly and securely to benefit greater community health.

Students will study healthcare informatics from an interdisciplinary perspective. This approach optimizes the synergy between technical knowledge, management principles and the medical field.

The intensive program, which students can complete in as few as 12 months, allows all students to understand, explain and eventually participate in collecting data as part of an FDA approval process. For example, the Health Information Exchange and Interoperability course covers the basics of critical concepts and practices of health information exchange and coordination. In the Fundamentals of Data Communications course, students may focus on the technologies used in various networks and how to transmit this information across the system.

Each future healthcare informatics professional will obtain the knowledge required to enter into influential roles such as clinical informatics analyst, health information technology project manager, health information specialist, health informatics consultant, EHR implementation manager and chief patient quality officer.

Learn more about the University of Illinois Springfield’s online Master of Science Healthcare Informatics program.

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