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الأحد، 28 أغسطس 2016

Understanding The Necessity Of FDA Regulatory Consulting

By Maria Cook


The U. S. Food and Drug Administration is responsible for the primary oversight of health and safety in America. As such, FDA regulatory consulting is often an undertaking by several different people in the organization. As part of the primary role of the agency, inspectors and investigators work to assure health and safety in all areas of business as related to food, drug and safety concerns and issues.

The USFDA is a subsidiary of the Department of Health and Human Services. While serving under this larger governmental umbrella, the agency is responsible for protecting and promoting health by monitoring tobacco, bio-pharmaceuticals, over the counter pharmaceuticals, dietary supplements, prescription medication, food and drink. The agency also provides oversight in areas related to cosmetics, veterinary medication, cat, dog and other animal food, animal and human vaccines, blood transfusions and radiation emitting products and devices.

It was the United States Congress which inspired the establishment of the organization. To do so, members created the Food, Drug and Cosmetic Act with the intention or provided higher quality foods and medicine to the citizens of the United States. While this Act is the primary focus of the organization, the agency also enforces other laws.

These areas include everything from cell phones and cell towers to sperm donations. While not related to food, these and other items all pose a safety risk to consumers. For example, there are currently ongoing studies with regards to cell phones and brain damage. If proven that cell phones cause brain damage, then more development and research will no doubt be necessary as related to future models.

The department lead in this area is the the Commissioner of Food and Drugs, a position appointed by the President of the United States. While the President has the ultimate decision on whom to place in this role, there is often welcome advice from members of Congress and the House of Representatives. As such, each election cycle, there is often a newly assigned commissioner. While these changes often occur with each newly elected president, the agency continues to maintain a main office along with several satellite offices regardless of this change in leadership.

Currently, the organization is scattered among a number of cities, towns, states and countries. While this is the case, there is a push to consolidate most of these departments into one location in Washington D. C. Although, there are two departments which will most likely remain in tact, these are the Office of Criminal Affairs and the Office of Regulatory Affairs. For, most employees of these two departments have and always will work from remote offices located in different regions.

The most well known aspect of the agency are health inspectors and investigators. For, these individuals inspect and report on all aspects related to food and drug administration. Most often, these individuals inspect various locations, investigate complaints, identify and investigate the cause of food borne illness and other outbreaks and review documentation as required.

Most often, restaurant owners, business owners, doctors, pharmacists and these individuals will consult with health inspectors or investigators. In most cases, a health card will be required to work at coffee shops, grocery stores and restaurants. If these cards are not on file, businesses often receive a warning and deadline. Businesses not adhering to this deadline can often face fines or closure as a result.




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