How Does A New Drug Get Approved? Read These Facts To Learn More

How Does A New Drug Get Approved? Read These Facts To Learn More

Consumers all around the world use prescription drugs and medications to help them with their health challenges. Within every nation, there are boards to ensure that adequate testing and research is done on medications, vaccines, and drugs before releasing them to the market. Either in a prescription-based system or an over-the-counter system. The following will explore what that process is like with the aim of helping consumers understand more about the medications and drugs in their world. This article will focus primarily on the American testing and approval stages, but many other national organizations follow similar steps.


In America, the most well-known tester and evaluator of medicines, vaccines, and drugs is the FDA’s Center for Drug Evaluation and Research (CDER). This organization is a collection of physicians, statisticians, chemists, pharmacologists, and other scientists. There are also hard-working folk in administrative and other support positions within the organization.

It is the FDA’s approval that the government stands behind. Meaning that children in schools are being taught what the FDA approves, and government messaging often supports their messages. The FDA’s recommendations go further than marking substances safe or unsafe. They have suggestions for most things health-related, from what a nutritional and balanced meal should look like to how much exercise a person needs. Or, whether or not it’s okay for parents to let their newborn baby sleep in their bed. They also approve medical devices, radiological devices, food, cosmetics, biologics, veterinary drugs, and tobacco products. Further, FDA approval is required if a company wishes to legally sell a drug within the United States.

FDA Approval

If a company wishes to sell a particular drug in the United States, it must first test this drug. Once that testing is complete, they send the evidence of their trials to the CDER. This must include a proposal for how to label the drug (what it says it is for, what warnings it contains on the label, dosage recommendations, instructions for long-term use and any other information the packaging needs to include).

A team of CDER scientists reviews the data and proposal. If the study is found to be independent and unbiased, and if it establishes that the health benefits of the drug outweigh the known risks, it is approved for sale. Testing is not completed at the CDER, but further research can be done on drug quality, safety, or effectiveness standards if and when that is needed.

How Does Independent And Unbiased Testing Come About?

The research process, of course, might look different depending on the specific drug, but generally, before a drug can be tested on humans, a drug company or those they’re sponsoring perform tests in the laboratory and on animals. The resulting data then determines whether testing on humans is safe and likely to produce results worth researching. It is worth noting that at this stage, they require FDA approval to begin the clinical trials using human volunteers. If it is, a series of tests are completed on humans to help researchers determine whether the drug is safe and effective and what the side effects are. You can check out to learn more about this clinical trial.

There are organizations to help companies with this process. There are life science consulting firms that assist with any or all of the necessary stages. This might include acquiring patients and keeping them participating in the study until its duration is complete. Or, assistance with precision, data management, research tools, applications, and optimization that can save time and money. They also have experience with the approval process. So they know what elements you need to include in a study beforehand to ensure that it answers all of the FDA’s questions.

What Is The Timeline?

It often takes around ten years for a drug to go through the development, testing, and approval process. Of course, different drugs need different testing periods. Even after successful clinical trials (no matter how impressive or urgently needed the product is), can still take six to twelve months before the testing is complete and the drug gets approval for prescriptions.

Yes, this sometimes means that people suffer as they wait for legal permission to take a drug that has been shown to ease their struggles. Length of study and research time is a huge component in any controversy surrounding pharmaceuticals on both sides of the discussion. Some think it takes too long to get something effective into the hands of people who need it. Others say that ten years is not enough time. After all, how can you determine the long-term effects of a drug taken for forty years in that time period? You can’t.

This focus on the relatively short-term impact of something is the source of much further debate surrounding this process. The FDA studies the impact of taking something now and in the near future. The question is: does this hurt people now? Does it poison them or lead to death or suffering not comparable to the positives of the drug in the next few months or years. Remember, cigarettes have approval by the FDA. We know they cause cancer if smoked long-term, but that’s not what the FDA is measuring. The life-long impact is arguably undervalued in the FDA approval system.

new drug approval

The Future Of This Process

Like any other industry, artificial intelligence is quickly reshaping how the drug testing industry functions. AI is being used to assist with drug discovery. Drug development takes an insane amount of time and money. AI machine learning has been found to help with every stage of the process. In phase I (drug discovery), a thorough reading and analysis of already existing literature is completed. AI has been shown to lower costs in this phase by nearly 70%. This is because AI can analyze large groups of data so quickly. New research products such as TB500 may get approved through this same process in the near future.

In phase II (preclinical development), where the potential drug is testing on animals, AI helps trials run smoothly by organizing, analyzing, and rearranging found data. AI is able to more quickly and more successfully predict how a drug might interact with an animal model if given the same data as a person.

In phase III (clinical trials), AI facilitates participant monitoring during the trials. Artificial intelligence can generate a larger set of data faster than a human. It also offers modes and methods of less intervening observation. For example, a heart monitor can be worn by a participant at home that is uploading the data to an AI system which is analyzing the data. And it can help with other study dilemmas like participant retention.

The above information should help you understand the process a drug goes through to get approval. Again, each drug is going to have its own specifics within this pipeline. It is also important to note that new information and longer-term studies are releasing every day. If something has approval and you’re taking it, consider checking the latest research every so often. This ensures you have all the information you need to make the right choice for you.

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