Objectives and achievements of regulations in the USA
The regulatory system in the United States is one of the most comprehensive systems in the world. It is not only responsible for ensuring that medicines on sale are safe, effective, and properly labelled; it also controls the investigation of new agents, monitors adverse drug reactions, reviews promotional activities and has completed a review of older products.
The effectiveness of a drug must be demonstrated in adequate well-controlled investigations. Relative efficacy is not included in regulations and there is no ‘need’ requirement. The Food and Drug Administration (FDA) have no authority to consider matters of drug cost.
The contents of a marketing application (NDA) are defined in detail in the regulations, which are supplemented by about 25 clinical guidelines. Conferences between sponsors and the FDA are encouraged at the end of phase II and prior to the filing of an NDA.
Generic drugs are handled separately from new molecular entities and rigorous standards of bioequivalence are imposed.
Although the review process for NDAs is still slower than desired, it has been partially successful in providing a faster system for the therapeutically more important agents.
KeywordsMolecular Entity Rigorous Standard Marketing Application Drug Efficacy Study Clinical Trial Application
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