Adaptive Partial Drug Approval

Currently the FDA requires that drug companies conduct 3 phases in order to secure the approval of a pharmaceutical. These are: Phase I. These are smaller (20-80 participants), clinical trials which determine a drug’s safety and pharmacologic properties among healthy volunteers. Phase II. This phase tests a drug’s efficacy and optimal dosage. Typically 100-300 individuals…

Is the FDA Safe and Effective?

The Food and Drug Administration is one of the most important government agencies. The FDA has an interesting history and below I will review some important dates. 1938 Federal Food, Drug and Cosmetic Act. This law was enacted after the drug Elixer Sulfanilamide killed over 100 people. Firms were required to submit new drugs to…