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The shift to modernize the drug review process helps the FDA identify the key issues and assess them on time with appropriate expertise.
FREMONT, CA: Modernization brings development in organizations. The change in our attire, food habits, electronic gadgets, and many more are the results of modernization. When basic needs of life are getting modernized, then why not the medicines? The change is evident in the food and drug administration (FDA) processes that examine the quality of food and drug produced by the manufacturers.
The new knowledge management approach
Recently, a new knowledge management solution was found by the center for drug evaluation and research (CDER), where an application is put forward in a structured format depicting the data regarding drug safety and efficacy by the manufacturers. Later, the formatted data is transferred to the FDA experts for timely evaluation. The purpose is to avoid uncertain issues and reiteration of PDF documents that are sent to the evaluation team for checking the data to clear the doubts about the analyzed product.
The shift in the process of reviewing the clinical data for new drug applications (NDA) and biologics license applications (BLA) undergoes a series of changes in analyzing and examining the data presented to the CDER's Office of Pharmaceutical Quality (OPQ).
Benefits of the new approach
The process helps in bringing digital transformation in the biopharmaceutical science and research department where a large amount of data needs modernization, which can ensure adequate evaluation. Also, the shift in the process helps in the reduction of cost for new treatments. To assess more applications for increasingly complex medicines, the review teams will analyze significant issues during the investigational new drug (IND) stage to focus on them accurately. After a series of evaluations, the advantages and risks mentioned in the documents are assessed, leading to greater transparency in the process.
For enabling smooth and automated workflow management system, the reviewing offices of CDER's office of new drugs (OND) are set up in large numbers, and this results in generating more data which is transferred to the cloud for efficient analysis. Thus, shifting to modernization helps the FDA to come up with new approaches for dealing with challenges like providing greater transparency in the regulatory process.