Other Free Encyclopedias » Medicine Encyclopedia » Aging Healthy - Part 1 » Drug Regulation - Discovery, Preclinical Testing, Phase I, Phase Ii, Phase Iii, Review By The U.s. Food And Drug Administration - Phase IV, Time and cost

Drug Regulation - Review By The U.s. Food And Drug Administration

clinical data clinical application trials

The FDA evaluates the data presented from the clinical trials in the New Drug Application (NDA) submitted by the manufacturer. The application consists of the application form and data from preclinical testing, chemistry and manufacturing data, clinical trials, samples and product labeling, and relevant publications.

The FDA evaluates the safety and efficacy of the drug and the quality of the data supporting the claims being made by the manufacturer. If approved, the product goes to market and enters Phase IV clinical trials.

Drug Regulation - Age Factors [next] [back] Drug Regulation - Phase Iii

User Comments

The following comments are not guaranteed to be that of a trained medical professional. Please consult your physician for advice.

Your email address will be altered so spam harvesting bots can't read it easily.
Hide my email completely instead?

Cancel or