Its time of the year where most of the Food and drug related companies are in a rush to get their FDA registration either approved or gets their FDA registration applications submitted. But before we plunge into the detail of the process we need to know
What is FDA?
Before you could bring about any medication to the market and make it available for the people’s consumption you need to get it approved from food and drug administration. The department is responsible to ensure the safety and security of the product for the consumer and therefore, you need to go through a hectic process of FDA approval where you could bring the medication to the market and make it available for the common public. Not only the process is a daunting task but also it is important to note that only 14 % of the drugs that are submitted for application get approved each year while the remaining percentage is rejected in their preliminary phases.
Therefore, you need to understand the process of FDA approval before you gets your medication approved by the department.
Organize Your Paper Work:
One of the many reasons for the ejection do the drug from the FDA department is due to the fact that most of the companies fail to fulfill the requirements of the paper work and therefore, you need to be specific with your documentation. You could check up on the site of FDA to ensure that you have filled all the required documents to ensure your approval. Moreover, you need to pay special attention to form 1572. This is considered as one of the key document in the investigation of the new drug and therefore, this needs to be in the fully equipped manner when you decide to present your FDA application for the new drug.
Present Measurable Evidence:
After the completion of the clinical trials one of the important step is to make sure that when Fda committee is reviewing the performance and the impact of the drug on the human health the pharmaceutical companies are able to provide with fruitful evidence that the trial have suggested the drug will be able to provide you with the safe and secure usage of the drug and also have deeper impact on the lives of the patients as compared to the existing drugs that are in the market.
If you lack the evidence to prove the point that the drug is effective and have safe and secure means of revitalization on the lives of the consumer then your FDA registration and approval process will be abounded and your application will be rejected. So, collecting the data and evidence before you apply for the FDA certificate is important.
Keeping A through Record:
When we are involving lives to our product it becomes extremely important to keep a record of the product from its pre-clinical trial, to vitro, vivo to animal studies. The applicant must ensure that all the procedure of the manufacturing, testing and the results have been established and the they are able to show the FDA authority why are certain recommended dose is suitable for the consumers and what studies have established the following results.
There are different criteria for different kinds of drugs relating to their side effects if the drug is providing safe evidence that it is expected to increase the life expectancy of the patients despite of its side effects it will get approved. But if the drug has side effects and not used for the terminal diseases there are rare chances that the drug is there to get approved before similar drugs are already there in the market.
For any of the new drug to get the FDA certification it requires at least 80 % of the subjects must show positive results. In order to prove the expectations and the results of the test the applicants needs to provide complete data to ensure that the drug gets approved by the authority. However, you might require the services of the FDA agent who could guide you to get all the paper work, documentation, data and the results of the analysis ready when the time comes for the FDA authority to consider your application.