Doctor Robert
Imani MD, PhD
More than 2 decades of Professional Experience in Pre-clinical, Clinical, Medical Affairs, Drug Safety and Post-Marketing Research of Investigational Medical Compounds, Product Launch, and LCM of Approved products.
About
Professional Experience in Pre-clinical, Clinical, Medical Affairs, Drug Safety and Post-Marketing
More than 2 decades of Professional Experience in Pre-clinical, Clinical, Medical Affairs, Drug Safety and Post-Marketing Research of Investigational Medical Compounds, Product Launch, and LCM of Approved products.
Doctor Robert Imani is a highly experienced medical professional with significant expertise in the development and approval of cancer drugs. Throughout his career, he has played a critical role in guiding pharmaceutical companies through the complex process of getting cancer drugs through FDA approval.
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.
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