Once a drug developer has created a new product that has proof from its previous tests and preclinical or clinical research that it effective and safe for the intended use, it’s time to submit an application to the FDA and get an approval for marketing the drug.
The FDA team will then examine all filed data thoroughly make the final to approve the drug or not. Here are 3 basic steps in the FDA drug review process:
1. Application for A New Drug
A New Drug Application or NDA will specify all of the information about a drug.
The primary purpose of this step is to show that your drug is totally effective and safe for the intended use in the studied population.
A drug developer should include everything about their new drug in the application, from phase III trial data to preclinical research.
Also, they should include reports on every analysis, data, and study.
In addition to clinical results, a drug developer must include directions for use, proposed labeling, drug abuse details, safety updates, patent information, and any data from research that might have been carried out outside the US.
2. FDA Review
Once FDA has received an application for a new drug, they will spend the next 6 to 12 months to decide if it is approved to market or not.
If the team thinks that the drug isn’t complete, they can refuse to approve the application.
The specific process is as follows:
Every team member will conduct a full review of her or his part of the application.
For instance, the statistician and medical officer will review all clinical data, while the pharmacologist will review all information from their animal studies.
After that, a few FDA inspectors will visit the clinical study site to conduct an inspection.
They will look for proof of manipulation, withholding, or fabrication of data.
The project manager will then assemble all of these individual reviews and other important documents into an “action package”, which will become the record for reviewing by the FDA.
The review team will issue a recommendation, and other senior FDA official would make the final decision.
3. FDA Approval
If FDA determines that the new drug has been proved to be effective and safe for the intended use, they need to work with the developer to create prescribing information, also known as “labeling.”
Labeling objectively and accurately describes the standard for approval and how the use the new drug best.
Although remaining issues often need to be addressed before the new drug would be officially approved for selling and marketing, FDA sometimes requires the manufacturer to answer questions based on the existing data.
In other cases, they might require additional studies.
If the application does not provide sufficient data for the review team to make the final decision over the effectiveness and safety of the drug, FDA might organize an advisory committee to get expert, independent advice.
This will allow the public to comment, and the FDA will get these perspectives to make a decision.
How Long I Will Take To Get A Drug Approved By FDA?
The review and approval process of FDA often takes from 6 to 12 months.
This can be frustrating, tenuous, and long, especially for those patients who are waiting on generic or new products to treat their conditions.
Though the purpose of the procedure is to ensure the drug effectiveness and safety of the patients, there might be a few unnecessary phases, which can be skipped to speed up in several critical situations.
The FDA has created 4 methods to accelerate their drugs approval process, including:
- Fast track: this procedure is created to expedite the development and review of those drugs which treat severe conditions and meet unmet medical needs.
- Breakthrough therapy: it is designed to speed up the approval of those drugs which are proved to be much more effective for a specific condition than the others available on the market.
- Accelerated approval: to be qualified for this process, your drug should meet unmet medical needs and have proof of possible clinical benefits.
Priority Review: if your drug us designated with this tag, it means that the FDA will make a decision within 6 months.