TABLE OF CONTENTS 
What are the functions of the FDA?
What is the importance of indications and endpoints in mapping a regulatory route?
How do FDA regulations affect pre-clinical and clinical product development planning?
Identify a path through the regulatory process for a drug, device or diagnostic product idea.
What are the contents of the submissions required by the FDA at various points?
How does a product with a combination of diverse technologies get approved?
How are personalized medicines developed through the regulatory process?
A brief history of the FDA proves useful to understanding the rationale and role of this organization in the healthcare system of the USA.
Federal oversight for drugs started with the establishment of US customs laboratories to administer the Import Drugs Act of 1848, as the US had become the world s dumping ground for counterfeit drug materials. However, the founding of the modern FDA is in the 1906 Food and Drugs Act. This act, establishing a national agency to put a stop to food adulteration and fake remedies, was passed in the context of trade concerns. Various trades and the public were concerned about the economics of varying state laws and the increasing use of new synthetic chemicals to create cheap and unsafe adulterated food (deodorized rotten eggs, revived rancid butter, substituted glucose for honey). Upton...
