Question

1. Discuss the role of the FDA. As you discuss please include the evolution of the FDA, why these evolutions matter today, and describe detail to demonstrate your understanding of Clinical trials/phases process, and including the goal in developing new drugs.

Answer 1

Discuss the role of the FDA.

• prevent sale of unacceptable food and drugs
• analysis of risks and benefits of any drug
• analysis of clinical trial reports
• reviews application for new biologics from bacteria and virus
• regulate all aspects of the process from manufacturing to quality control to labelling to advertising
• facility inspections
• regulates medical devices and diagnostic kits
• protects and promotes health and economic interests by ensuring that food are safe, nutritious and honestly labelled.

As you discuss please include the evolution of the FDA, why these evolutions matter today.

• 1906 : Pure Food and Drug Act

Creation of the FDA

• 1907: creation of the Board of Food and Drug Inspection and the &
• 1908: creation of the Referee Board of Consulting Scientific Experts ; as separate organizations within the USDA
• 1927: the Bureau of Chemistry's regulatory powers were reframed under one new USDA sector, the Food, Drug, and Insecticide organization.
• 1930: the name was shortened as FDA

These evolutions are of great importance as they regulate the base of current functioning of the FDA.

Describe detail to demonstrate your understanding of Clinical trials/phases process, and including the goal in developing new drugs

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