The Roles and Responsibilities of the FDA Essay

The FDA is charged with protecting consumers, patients, and enhancing public health globally by maximizing compliance of FDA regulated drugs, products, and devices and minimizing risk associated with those products. While FDA’s overarching mission remains the same, it has added additional products to regulate and further expansion of its global reach. FDA is now responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is tasked with helping speed innovations by getting products, with accurate, science-based information, to the public and ensuring that the medical products are safer and more affordable. Increasingly, FDA also plays a critical National’s counterterrorism role by ensuring the security of the food supply and by developing medical products addressing deliberate as well as naturally emerging threats.…

1.1 Background The mission of the FDA Office of Financial Management (OFM), Division of Financial System Support (DFSS) is to coordinate the management of FDA’s financial system of record Unified Financial Management System (UFMS) with Health and Human Services (HHS) and the other HHS Operating Divisions (OpDivs) who currently use UFMS. UFMS is the HHS department wide financial system of record. The HHS Financial Enterprise System Management (FESM) organization is responsible for managing the…

I chose to discuss the scenario a new childhood vaccine developed by the NIH, approved by the FDA, endorsed for the federal payment by the CDC and recommended for the use by the American Academy of Pediatrics. The question posed is as follows: do all these agencies and organizations always work so well together? What exactly is the American Public Health Agencies and its role? The American public health is often equated with the work of governmental agencies. The role of the government is…

adequately access the environmental impact of Monsanto’s Roundup Ready sugar beets” (Waltz 970). Unfortunately, this was not the first instance that the USDA has failed to access the environmental impact of Monsanto products. Monsanto’s bent grass and alfalfa were also released into the market without the USDA fully evaluating the environmental effects. The agency failed to write an environmental impact statement, required by the National Environmental Policy Act. The USDA has “interpreted its…

HACCP is a food safety method used internationally, U.S. Food and Drug Administration defined HACC as a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product (FDA, 2015). In the FSMS, not only food safety regulation authorities, such as Food Standard Agency (FSA) and Department of Environmental…

common as a result of all of the different angles to be considered. One controversy in particular that has received much attention is on the issue of emergency contraceptives, or the morning-after pill. In 2013, the FDA approved the Plan B One-Step pill to be available to women ages 15 and older without a prescription. What factors went into making this decision,…

Dover, Delaware. My employment here has always been working in the Quality department where I manage the Device History Records department. A department that reviews, approves and manages all documents from the manufacturing floor. The manager that has given me guidance and advice during my career is Norman Hahn. Norma has many processes that he oversees such as Corrective and Preventative Actions, Material Review Boards, and Quality Systems requirements, as well as assisting other managers…

the lack of consciousness of the food we are ingesting the effects it has on our bodies, as well as the role the government plays in regards to American obesity and disease. In a survey done by the FDA in 2008 in every state including The District of Columbia on adults, it indicates that “55 percent “often” use the label to get a general idea of the food's nutritional content. That is a little more than half of the general public. The study also shows that “Thirty-eight percent of consumers…

learning activity at the end, complete the following questions: • Briefly explain what the FDA is, it’s mission, and how it achieves its mission. FDA (U.S. Food & Drugs Administration): It is a federal administration which protects the safety and public health of the U.S. The mission of the FDA is to ensure the safety of every American family by ensuring the control and the potency of the products offered to the population, such as food supply, cosmetics, medical devices, medications, and…

Critical Point Three: Prescription Drug User Fee Act With the FDA budget still unadjusted for inflation and slashed from Reagan’s Regulatory Relief program, the agency was severely understaffed and under-resourced. Though the parallel track and treatment IND programs decreased the trial periods and drug lag for drugs helping “life-threatening conditions,” the average drug review period was still over a year. FDA management was struggling to decrease review times across the board with the added…