The Process
The Process Of Moving
Through The FDA
Developing a new cancer drug is a complex and multi-step process that requires extensive preclinical and clinical testing before approval by the US Food and Drug Administration (FDA). Here are the general steps involved in getting a novel investigational medicinal product through FDA approval:
Preclinical Testing:
In the preclinical testing stage, the drug is tested in laboratory settings and animal models to determine its safety, efficacy, and potential toxicities.
Investigational New Drug (IND)
After preclinical testing, the drug developer files an IND application with the FDA, providing all the data obtained during preclinical testing.
Phase I Clinical Trials:
Phase I clinical trials involve testing the drug in a small group of healthy volunteers or patients to determine the safe dose range and any potential side effects.
Phase II Clinical Trials:
In this phase, the drug is tested in a larger group of patients to evaluate its efficacy and to identify any potential side effects.
Phase III Clinical Trials:
In Phase III trials, the drug is tested in a much larger group of patients to confirm its safety and efficacy compared to existing standard treatments.
New Drug Application (NDA)
After successful completion of Phase III clinical trials, the drug developer submits a New Drug Application (NDA) to the FDA, which includes all the data collected during preclinical and clinical trials.
FDA Review
The FDA reviews the NDA, and if the drug meets safety and efficacy standards, the FDA approves the drug for use.
Post-Approval Monitoring
Once the drug is approved, the FDA continues to monitor its safety and efficacy in real-world settings, and the drug developer is required to submit periodic reports to the FDA.
Doctor Robert Imani has extensive years of experience in this area.
It is important to note that the process of getting a cancer drug through FDA approval can take many years and cost billions of dollars. The success rate of drug development is relatively low, with only a small fraction of drugs making it through all the stages of development and approval.
