Question

Identify two articles from the published literature that make recommendations about the U.S. Food & Drug Approval process. In your own words, provide feedback on their recommendations.

Answer 1

Consumers in America get benefit from having safest and most advanced pharmaceutical system in the world.

**The consumer watch dog in America is FDA, It is a regulatory body which will look after whole research to make sure the safest and efficacy medicines should be marked.

FDA Team includes of physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling and then provide decision on approval.

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

During the research or producing generic medication it will perform audit to maintain quality production of drugs. If the Drug Company or sponsor does not meet the recommendations of FDA, it will block the company.

** FDA believes that scientific and regulatory recommendations provided during drug development meetings with sponsors may result in more efficient and robust development programs