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New age medicine is an exciting field with the exciting possibility of helping millions of people. However, it is crucial that these treatments go through extensive testing to prevent any unwanted side effects and fatalities. The process these medicines must go through to get FDA approval is lengthy and demanding. Luckily, there are best practices that can help drug manufacturers reach FDA compliance more quickly.
Prepare to File an NDA
In this case, an NDA stands for New Drug Application. The NDA is the form that all drug sponsors must submit when they ask the FDA to approve. This application is not just a form, though. It is an extensive way to test what your drug does against what it is supposed to do. Overall, the FDA reviewer is trying to determine if the proposed labeling, the manufacturing methods, and the drugs themselves are safe and effective.
There are many resources provided by the FDA to help you prepare a successful NDA. These include documents on formatting guidelines and various regulations. Do your research. No one wants to waste time getting rejected for formatting mistakes.
Check Your Medicine
Scheduling a consultation with Compliance Insight is another savvy step to take before officially applying for FDA approval to increase your chances. Some companies, like Compliance Insight, know that some companies employ FDA regulatory and quality compliance experts to show others the right path toward FDA approval.
The FDA regulatory process can be strenuous and complicated. It is often difficult for drugs to reach compliance. This company not only helps its clients to understand the FDA rules but works to improve their client’s manufacturing processes to make them more efficient.
Prepare to Go Through the Official FDA Phases
One more thing you must do to get FDA approval is to understand the phases the medicine will be going through. There are five primary phases of FDA testing, and it must pass each phase to move on to the subsequent one. These phases are called discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. While the NDA is a crucial part of the process and should be the first thing companies review, it is not the first thing companies must do to get FDA approval.
Instead, companies conduct and pass laboratory tests that show the drug is effective and safe for animals and people. A common misconception is that the FDA tests the drug. The FDA does not test the drug before making an approval decision. That onus is on the company, and the FDA will review the results of those tests.
They will also look at the research that supports the drug’s capabilities and determine if the study is sound. After the FDA review, they will continue to monitor the drug in the market and strike approval if it is unsafe. Be sure to familiarize yourself with this entire cycle.
This way, you do your best to reach compliance without suffering many rejections. Remember that the medicine’s labeling and manufacturing methods will be just as scrutinized as the drug itself.
Consider Pushing for Accelerated Approval
Lastly, you can consider pushing for Accelerated Approval. As previously stated, the FDA approval process can take years. However, Accelerated Approval is a pathway designed by the FDA to expedite the process for medicines that could treat critical conditions.
Medicines designed to fight diseases that take a long time until fatality benefit from this pathway the most because a longer time is needed to test effectiveness. The qualifications for Accelerated Approval are detailed on the FDA’s website, so check to see if your new age medicine would be a good fit.
It is not an easy road to get FDA approval. However, by doing your research and consulting with third-party companies like Compliance Insight, you can set yourself up for success and make the process much easier.
