Regulatory Agency Paper

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

FDA stands for Food and Drug Administration, it is responsible for protecting the public health by assuring that foods are

FDA’s Center for Drug Evaluation and Research (CDER) works to ensure that the drugs release in the market are safe to be used by general public. They evaluate prescription as well as non-prescription drugs for their safety effectiveness and quality. They review the drug before being marketed to improve overall health

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

Compliance with legislation. Ensure safety of customers, contractors and staff at all the times. The enjoyment of these standards at the highest levels is a basic human right that should be accessible by each and every worker. Regardless of the nature of their work, workers should be able to

Consumer protection laws are federal and state statues governing sales and credit practices involving consumer goods. Consumer Product Safety Commission, Unfair or Deceptive Trade Practices, Truth in Lending Act, Fair Debt Collection Practices Act, Warranties and Consumer Remedies are laws that were establish to give the consumer a fair shake at buying or borrowing money. Goods that were purchase or service for personal use were presumed fair that buyers and sellers would bargained for equal positions. The consumer protection is a law that has to contribute to safety, protecting the health of consumers and the economic interest of consumers. Local trade practices consider unfair or deceptive may fall with Federal Trade Commission laws and regulations and have an effect on interstate commerce. Federal and state laws governing sales, credit financing and reporting, product quality, leases, sales practices, debt collection and other aspects of consumer transactions may be regulated as deceptive trade practices. Consumers are protected by several types of agencies and statues that are enforced by state and federal laws. Today many of consumer protection issues are involve with the

The Food & Drug Administration became a possibility because of the Pure Food and Drugs Act of 1906. Harvey Washington Wiley was the driving force behind this law and headed its enforcement, which provided basic elements of protection that consumers had never had before (FDA's Origin). The FDA is an agency that works within the US Department of Health and Human Services of the executive branch of government (About FDA). The Food and Drug Administration is responsible for protecting the public health of all Americans by ensuring the safety, efficacy, and security of a large range of products from drugs to cosmetics (What We Do).

From a staff of one to over 9,000, the Food and Drug Administration has seen great changes since it was first created in 1862. Stemming from a single chemist in the U.S. Department of agriculture, the FDA now encompasses most food products, both human and animal drugs, cosmetics and animal feed.

The scope of the drug development process is defined to prepare the audience to understand the role of regulatory affairs professionals. Responsibilities and roles of regulatory affair’s professional are explained and described in the presentation. However, the functional role of a regulatory affair professional in cross-functional area has not been included. Addressing the Importance of communication skills and experience can provide added incentive to the reader for personality or characteristic of the profession. The presentation is direct to the point and delivers basic understanding of the role to the audience. However, it can be expanded to include additional details such as educational prerequisite and job characters to describe the professional

Although the Ombudsman program has no authority to set or enforce specific standards of care, the program has been found to be a positive, if under-resourced, influence on quality of care. Take for example, the government enforcement of quality

Is Americans health on the decline? The government seems to think so. There are many ways the government should change the regulations. I think the government should change the regulations to help better our lifestyle.

The U.S. Consumer Product Safety Commission, have to protect the consumer from dangerous risk of injury of death that is associated with many kind of consumers products under the agency’s jurisdiction ( wwwprnewswire.com/news 2015). There have been many deaths and it has caused the world trillions of dollars annually, there has also been chemical and mechanized hazards, Products has worked hard to make sure all products are safe (Seaquist, 2012).

Many people believe that government regulations are important in safeguarding individuals against dangerous substances or situations. Amazingly, people see government as a trusted entity that gives people’s interest a priority. In fact, when individuals see government regulating and licensing restaurants, banks, restaurants, medical doctors, daycares, physicians and other businesses, they contend that government is striving to ensure that their products and operations are safe and there is no risk or harm will emanate from them. Indeed, I have heard occasionally individuals arguing that he/she would not use a cab without government inspection certification. On the other hand, individuals normally are regarded as being incapable or compromise on their health and safety just to achieve what they want in the sense that they can consume anything or resort to the use of any services or products like drinks with sugars larger than 16 ounces, without serious considerations of their health and safety. Therefore, people should be dictated on what they do or what not to do to guarantee them their safety. However, in my view, government regulations do not guarantee us safety; we are responsible for our own safety.

In the FDA, all medicines or innovative products or generic, need to be approved before production would or would become available for patients in every FDA Member State must bear the responsible authority or the FDA, examines and evaluates medicinal products for every market quality, safety and