FDA Approval Process – Overview
Medical treatments and newly invented drugs in the US must undergo a specific process under the FDA, i.e., the Food and Drug Administration department.
This process ensures that the medical treatment or the drugs are safe to use on the public.
The department monitors the process of approving new medicines or treatments from scratch. This article explains the entire FDA Approval Process in detail.
FDA Approval Process
How do you get into the FDA approval process?
The Food and Drug Administration department takes care of the FDA Approval Process. The FDA Approval process depends upon the product type or the medical treatment.
The department doesn’t require your approval for all products. However, FDA approval is required if the product falls under a special category.
What Types of Products and Categories Need FDA Approval?
The FDA requires approval for drugs, biologics, and medical devices, and some edible products.
The same approval is needed for inventing and launching new drugs or medicines or new medical treatments.
Here is a list of all the products and categories that require FDA Approval to be sold in the open market.
FDA Approval is required for the following products
- New drugs
- Biologics
- Certain medical devices
The FDA must approve drugs and medical devices before marketing, but foods and dietary supplements do not receive FDA-approved labels. The FDA does not approve cosmetics.
If you wish to add the FDA Approval label on your products that don’t require FDA Approval, you will have to apply for their permission to show their tag on your products.
FDA Approval Process
1. New Drug Application
The preclinical research process comes first when a drug company starts developing its new drug.
Before the medicine is used on humans, the company has to go through the testing phase of its new drug on animals. The company has to file an Investigational New Drug application.
The application must mention the human trials and other phases of drug development.
The FDA department first examines the Investigational New Drug application applied by the sponsor.
After conducting a survey, they will approve the application and allow the company to undergo human trials. If they find anything wrong, they will reject the application.
Once the company develops a drug, it will require another approval from the department after several years of laboratory testing.
This statement is misleading. The success rate for drugs moving from the first phase of clinical trials to FDA approval varies and is not as low as 1 in 1000. According to available data, the probability of approval for drugs that have entered Phase 1 trials is estimated to be higher.
2. Phases for Human Investigational Drugs
If the FDA approves the Investigational New Drug Application, the drug will enter a new phase: human trials.
The human trials of the new drugs will have to go through four different phases. Let’s collect more information about the various phases of Human Investigational Drugs.
Phase 1:
In this phase, the company will call up volunteers. Around 80 volunteers will participate in this process to ensure the drug’s safety. This phase takes at least one year.
Phase 2:
In this phase, the effectiveness of drugs will be determined. The company will call up over 300 patient volunteers to evaluate the effectiveness of their medications against certain diseases.
This phase will take two more years. The phase also conducts surveys for two years and notices the side effects of the drugs on the patient volunteers.
Phase 3:
After completing two years in the second phase, the third and the final phase will come up.
In this phase, thousands of volunteers will visit clinics and hospitals to test the drug’s effectiveness on a larger scale.
In this phase, unlike the first two phases, humans of all age groups check the drug’s effectiveness in different age groups.
3. New Drug Application
After completing the human investigational drug’s human trials and testing phase, the company must submit a New Drug Application to the FDA.
The application must be submitted with complete reports of the human trials and their results in all three phases.
A New Drug Application is the official request for approval from the Food and Drug Administration department of the US Government.
The application includes all the details starting from the animal trials, human trials, and their phases, side effects, effectiveness, effectiveness period, the effectiveness of the drugs on different age groups, and more.
Besides this, the application has to mention how the drug will react to the body and how it will cure particular diseases in human beings.
The FDA has 60 days to decide whether to file a New Drug Application (NDA) for review.
4. FDA Advisory Board
FDA Advisory Board includes a group of physicians and other professionals who conduct a meeting to discuss the NDA.
The FDA reviewers and the new drug manufacturer will also be present during the meeting.
The meeting usually lasts up to two days. After that, they will recommend whether to approve or reject the NDA to the FDA.
They will do this through the voting process. The team includes all types of professionals from the medical industry to ensure a fair decision.
5. Final Drug Approval
The final drug approval comes after solving the patent disputes if there are any. Even if the new drug gets FDA approval, it will take some time to come on the market.
The pricing of the new drug comes after the FDA approval.
The FDA Department’s duty is not over yet, as they will still monitor the newly approved drugs. The fourth phase of human investigational drugs involves surveys to determine the products’ actual effectiveness and side effects.
The Final Words:
This is how the FDA department works, and it approves the new drugs and edible products that manufacturing companies produce.
The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from drug manufacturers to fund the new drug approval process for faster review times. The FDA has separate ‘fast track’ and ‘breakthrough therapy’ designations for drugs that address unmet medical needs.
Under this law, the FDA can collect fees from the manufacturing company to expedite the drug approval procedure.
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