My tests had several questions that referenced to the drug approval process. I suggest that anyone planning to take the MPJE for any state be familiar with the drug approval processes
Investigational New Drug Application
•1stapplication before drug is given to humans
•Federal Drug Administration (FDA) has 30 days to decide if suitable for testing
•Must provide clinical protocols to be used in human testing
Clinical Trials
Initiated after FDA approves the investigational new drug application
3 phases before marketing and 1 phase after marketing
Phase 1: Small group of healthy individuals to evaluate toxicity, kinetics, safety
Phase 2: Large group (100+) with the disease being treated to evaluate effectiveness, safety, and adverse drug events (ADEs)
Phase 3: Large group (1000+) to evaluate effectiveness, double-blinded with placebo
Phase 4: Post-marketing surveillance to determine if drug should stay on the market
New Drug Application (NDA)
Can apply once data on safety, efficacy, toxicity, stability, production methods, packaging and clinical trial data exists
Typically takes 6 months for review
Abbreviated New Drug Application (ANDA)
For introducing a generic of an already approved drug
Requires proof of kinetics, bioequivalence/bioavailability
Supplemental New Drug Application (SNDA)
For changes to synthesis, production, manufacturer location, packaging and/or labeling
For new dose form, strength or therapeutic use
