Explore the FDA approval process for new drug development, from preclinical research to the final decision. Learn how BioBoston Consulting can assist you in navigating this complex journey.
Here is a step-by-step deeper dive on the FDA approval process, from early-stage preclinical research to final decision for market inclusion. It is a comprehensive procedure for formulating an entirely new drug to receive permission from the U.S. Food and Drug Administration (FDA). This important achievement guarantees that the drug adheres to highest safety and efficacy measures allowing it to be accessible by people.
In this article,we will also explore how working with Bioboston Consulting can help you navigate the complicated FDA approval process.
Preclinical Research
Preclinical research is the basis for drug progression through FDA approval stages.
Lab-based testing and animal trials are performed to confirm the safety and effectiveness of this medication. Preclinical work complies with FDA regulations and ensures that the data going into phases 1–3 is rock-solid.
IND Improvements
IND application submission is an important step after preclinical research. The application describes the proposed clinical study using information from preclinical research.
The IND application is critically reviewed by the FDA, which provides significant feedback and input on prospective clinical trials.
Clinical Trials
Drug reaching Clinical trials is a new milestone in drug development. First phase involves healthy volunteers followed by patients to test the safety and usefulness of drug in different segments.
Strictly following the protocols provided under IND Application keep the trials results valid.
New Drug Application (NDA)
When the clinical trials are finished and the data is rigorously analyzed, a New Drug Application (NDA) that contains all this information in one document is prepared for submission.
The comprehensive submission includes safety and efficacy data, proposed labeling for the product and manufacturing information intended to support quality control of the vaccine. This submission will be reviewed in-depth by FDA.
FDA Review
FDA: The FDA examines the NDA in detail studying drug safety, effectiveness and manufacturing procedures.
This stringent evaluation verifies that the drug is made in such a way it can be manufactured over and over again and accurately priced. During the review, FDA may ask for additional information or clarification.
Approval or Rejection
The FDA finally decides to accept or reject the application, and in some instances requests further information. After FDA approval, the drug is allowed to be sold, thereby completing a very long meticulous journey of the drug.
Conclusion
However, the FDA approval process is complex and requires thoughtful planning to navigate every step with great precision.
Armed with this knowledge, companies can more confidently navigate the myriad of complexity surrounding FDA approval and ultimately ensure that their life-saving and quality drugs get into the hands of patients in need.
If you would like to discuss the specific details of your project with BioBoston Consulting, do not hesitate and contact us today or visit our website.
