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The United States Food and Drug Administration (FDA or USFDA) is an agency that is part of the United States Government. The FDA’s purpose is to protect the public from harmful food or drugs. The Food and Drug Administration also promotes health and educates the public on issues of nutrition, dietary needs and medical pharmaceutical matters. A list of food and drug related items that the USFDA is in charge of is as follows:
The Origin of the FDA
President Theodore Roosevelt created the Food and Drug Administration in 1906 and was originally called the Food, Drug, and Insecticide Organization. The purpose was to monitor hygiene and protect the public from harmful chemicals.
The FDA regulates 25% of all US consumer purchases. This amounts to almost $1 Trillion of US citizen’s money. The budget for the FDA in 2012 was $4.36 Billion.
One of the most significant oversight functions of the Food and Drug Administration (FDA) is ensuring that pharmaceuticals, biologicals, and other substances used in the provision of medical treatment are effective and safe. At the same time, the agency understands and validates the urgency of the development process, and as such, has sought to minimize and streamline its oversight and approval channels wherever possible to ensure that effective treatments are available to the consumer.
The Ever Changing FDA
However, the rapid pace of the technological advancements and scientific development that has transpired in recent years has rendered many of the FDA’s existing regulatory standards largely obsolete. Acknowledging this challenge, the FDA has developed and implemented a new approach to its manufacturing standards that is based on a new paradigm of risk assessment. The revised approach, released in 2004, is known as risk-based good manufacturing processes (GMPs). This discussion will offer an overview and analysis of the impact and implications of these changes for the FDA, the health care manufacturing sector, and the consumer.
During the process of modifying, revising, and updating its GMPs, the FDA also engaged in several extended comment periods, in which both consumers and industry participants were invited to offer pertinent feedback on the processes that were being reconsidered. In light of the suggestions that were offered, the agency made several substantial changes to its proposed revisions. The FDA leadership has noted that it recognizes the central importance of ongoing communication, discourse, and knowledge transfer in order to optimize the quality control processes that will lead to greater safety and availability of pharmaceuticals, biologicals, and other health care products.