New Drug Application (NDA) Process

Question 1

New Drug Initial Development

Answer 1

-Pre-Clinical
· Pre-Clinical (animal) testing.

-Investigational New Drug Review (IND)
· Review of of Pre-clinical Trial results.
· Determination of safety to use on humans.
· Authorization to ship across state lines.

Question 2

Phase I

Answer 2

· Involves a small number of healthy volunteers (25-100).
· Safely tolerated dosages determined.
· Identification of major side-effects
· Emphasis on safety and maximum tolerated dosages.

Question 3

Phase II

Answer 3

· Involves many more volunteers (100-300).
· Emphasis on the drugs effect against what it’s designed to treat.
· Effects compared with similar patients receiving different treatments.

Question 4

Phase III

Answer 4

· Involves a few more volunteers (300-3000).
· Emphasis on the drugs overall effect.
· Effects compared with patients unknowingly taking placebos
· Study of different populations and different dosages.
· Testing the drug in combination with other drugs.
· Final Phase before presenting to FDA for approval.

Question 5

Phase IV

Answer 5

· Ongoing/Post approval trials.
· Health-care professionals to report any adverse findings.
· This phase lasts eternally, as long as the drug is on the market.

Question 6

Time the Process Takes

Answer 6

This process can usually take 12-15 years. The time elapsed from a drugs discovery in a lab until it becomes available to market to the general public can be even longer. Keep in mind that a Patent only lasts 20 years from the time the application for patent was filed. After the patent runs out, competitors may seek approval to produce Generic drug equivalents. Also, It is estimated that less than half of new drugs approved for clinical trials ever make it to Phase III and less than 20% make it to market with FDA approval.