Question

explain the difference between the Investigational New Drug and New Drug Application

Answer 1

Pharmaceutical Drug's review process starts with IND(Investigational New Drug) application which is submitted to US FDA(UnitedStates Food and Drug Administration). Investigational New Drug process is the means to get approval to start human clinical trials of the drug and ship the drug across the State lines to the investigators before marketing of the drug has been approved.

For any drug to obtain approval for sales and marketing in U.S., NDA(New drug application) must be submitted by the manufacturer which provides data on animal and human studies, toxicology and pharmacology of the drug, dosage and manufacturing process. NDA provides FDA reviewer with adequate data to ensure the safety and efficacy of the drug. FDA takes 60 days to approve or reject the application.