What does artificial intelligence enter into the FDA decisions mean?

June 22, 2025

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A shift in the pharmaceutical market .. What does the FDA resort to AI mean?

In a move that may re -draw the entire medical innovation scene, and shorten years of waiting, the US Food and Drug Administration (FDA) moves, to adopt artificial intelligence as a basic arm in drug reviews and medical devices, which will radically increase efficiency, and speed up the issuance of approval decisions on new medicines and medical devices.

This is one of the most prominent priorities that the US Food and Drug Administration has set for itself, in an article published recently in the Journal of the American Medical Association (JAMA), where Dr. Marti Macari, the FDA Commissioner, explained that the administration will focus on accelerating the provision of effective treatments for patients, especially for those who suffer from rare or neglected diseases, in addition to enhancing the quality of food allocated for children, and all by adopting an approach Daughter to restore the confidence of the public.

Medical similar to Chatgpt

According to a report prepared by the “New York Times” and was seen by the “Sky News Arabia Economy” website, officials in the Food and Drug Administration want to reduce the time period needed to issue decisions to approve medicines or new medical devices, from the most famous or years to only a few weeks, documenting this to the experience of the “high speed” program, which is successful during the Kofid-19, and in implementation of the map of the new road, which you set The Trump administration, aimed at paving the way for major industries to deliver products to pharmacies and rapidly shelves of stores.

During the past week, the US Food and Drug Administration launched a new artificial intelligence model called “Elsa”, a multi -language model that is somewhat similar to the ChatGPT program, and it can help define the priorities of the factory and food and pharmaceutical installations that need inspection, writing summaries about the side effects of the drugs, in addition to performing basic review tasks for various medical products.

The FDA officials said that “Elsa” may greatly help accelerate the review of up to 500 thousand pages submitted within the framework of decisions to obtain the necessary approvals to launch medicines and medical devices, while the FDA Commissioner, Dr. Marti Makary, confirmed that the “Elsa” model was not trained based on data issued by pharmaceutical companies, or about medical devices production companies.

The Food and Drug Administration is currently playing a pivotal role in implementing the agenda of the US Minister of Health, Robert F. Kennedy Son, I have already started pressing food manufacturers, to get rid of artificial food dyes,

But some aspects of the proposals that are working to apply the FDA, especially the idea that artificial intelligence is able to shorten months or years of work, has been skeptical, as official and precedent medical officials said that the artificial intelligence tool is useful, but it is far from making a fundamental change due to the need to carefully verify the results that it issues, which means that the final result is to provide a little time until now.

Establishment is extremely important

The head of StMC Hospital, Dr. Fadi Hashem, says in an interview with the “Sky News Arabia Economy” website, that the entry of artificial intelligence in this way to the processes of reviewing medicines and medical devices within the FDA is a very important development, but it requires a lot of scientific caution in the application, indicating that accelerating the review of medicines and devices is a completely legitimate goal, especially in cases of rare and incurable diseases, as every day of delay may mean losing a sick life or losing an opportunity Therapeutic, so if artificial intelligence is able to liquidate huge amounts of initial data faster and more accurate, this allows medical teams to focus on deep clinical analysis, rather than drowning in administrative details.

The doctor decides the decision

Dr. Hashem, a urologist, AI programs and tools are able to analyze complex clinical data, by understanding the biological and pharmaceutical context accurately, which helps them to discover statistical relationships, which human auditors may not notice in traditional analyzes, stressing that artificial intelligence programs are not a substitute for human medical evaluation, as decisions about the safety and effectiveness of medicines may be It cannot be based on automatic predictions alone, but rather you need an in -depth clinical reading that takes into account the differences between population groups, the overlapping of chronic diseases and rare long -term side effects, which may not appear in the initial databases, and therefore the decisive decision should remain in the doctor’s hand.

Clean and unbiased data

Dr. Hashem, that the issue of training the FDA model for artificial intelligence “Elsa”, on medical data that is not subject to the influence of pharmaceutical production companies, is an important matter in a scientific point of view, as it reduces the possibility of bias in the algorithm, so transparency in data sources of any medical artificial intelligence model is one of the most important guarantees of the integrity of the results and its lack of scientific or moral deviation for the benefit of pharmaceutical companies, stressing the necessity of investing artificial intelligence. To reduce the time gap, between discovering treatment and reaching the patient, without prejudice to the level of scientific safety, which is the backbone of any treatment decision.

A step to reshape the medical sector

For his part, the technological developer, Hisham Al -Natour, says, in an interview with “Sky News Arabia Economy”, that the American Food and Drug Administration is doing today, including integrating artificial intelligence models at the center of the processes of reviewing medicines and medical devices, is indeed a qualitative step that may reshape the structure of organizational approvals in the medical sector, indicating that the launch of the “Elsa” model specially designed to work within the complex medical and organizational data environment It represents a remarkable technological leap, as we are talking about algorithms capable of dealing with thousands of pages, which were previously required a large human teams that work for months or years to examine them.

Risk monitoring accurately

Al -Natour explains that the introduction of artificial intelligence in the process of reviewing new medicines will reduce the volume of data that people need to review manually, as smart algorithms will be able to sort this data primarily, and will determine the critical points or signals that need an accurate human review, and this in itself will shorten months of continuous work, stressing that the positives of this technology are not limited to speed The ability to monitor the invisible patterns of humans easily, such as the exact indicators that may indicate potential risks or exceptional effectiveness of a specific drug.

A wave sweeping the world of medicine

According to Al -Natour, what is happening with the FDA today is merely a reflection of a broader wave sweeping the world of medicine thanks to artificial intelligence, which has become a key player in developing medicines across the so -called AI DROG DISCOVERY or artificial intelligence in the discovery of drugs, where mathematical models are used to design new drug molecules, within weeks instead of traditional laboratory experiences, as this technology has become a role in a role in Diagnosis of diseases of radiology and laboratory analyzes more accurately than some specialists, stressing that the world stands in front of a real medical revolution led by artificial intelligence, in the entire health care chain from the laboratory to the patient’s bed.