Fda 's Drug Approval Process : History, Pre Market, And Post Market

The FDA has come a long way since 1906, but in my opinion, I believe that the FDA should do more to protect our health and have stricter laws in place concerning our food and medicines. The FDA allows products to be on the market without prior approval; for the FDA to take action and recall a product something awful like multiple deaths have to happen for them to realize that the product is harmful. Prime example, Red #3 is food coloring that FDA permits in our food to make the food look appealing. However, studies done on animals have proven to show that Red #3 causes cancer. According to an article published in 1990 in the New York Times states that "Red Dye No. 3 still has some approved uses in foods and drugs, but the F.D.A. said it is

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.

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).

The Food and Drug Administration has an important role in keeping people healthy. They dictate food labeling and quality control of the food that reaches grocery store shelves. Along with overseeing safe food practices, they control what medications are brought to the public. When a new drug is brought to the FDA, they will test it extensively before allowing

Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).

The FDA’s regulations would impact the food and drug production industries in multiple ways. Firstly, the regulation decreased the quantity of goods that the companies had available to sell. For example, before the Pure Food and Drug Act, meat-packing companies could pack and sell deceased animal meat, like from dead cattle. The sum of the dead

research. (Grounder, 2013) Today pharmaceutical companies are held to a very high safety standard when it comes to marketing

The FDA’s origin did not begin as the federal consumer protection agency it is widely recognized for being today. Prior to the FDA transforming into the present-day agency, the FDA’s emergence can be traced back to the agricultural industry during the 1800’s (History, 2015). In fact, it was Congress that enacted the FDCA (Food, Drugs, & Cosmetics Act) of 1938 that created the modern-day FDA (Allen, 2013). Despite the FDA’s passing of the tobacco law, the ongoing issues concerning the under and over regulation of products, and the high number of drug recalls suggests that the

The U.S. Food and Drug Administration (FDA) is the governmental division that protects the public’s health by guaranteeing food, drugs, and medical devices are safe and effective. It assures that dietary supplements and cosmetics are well labeled, regulates tobacco, protects the users from electronic product radiation, among others.

“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products,

The FDA behaves in ways that enhance its reputation for protecting consumer safety and public health. As gauged by public opinion polls, the FDA remains one of the most popular agencies in government, regularly securing 70 percent or greater “approval” of its performance among sampled respondents.5 Buttressing this popularity are powerful symbolic lessons of history: The FDA is widely credited with saving thousands of American lives in its response to the sulfanilamide tragedy of 1937 and the thalidomide scandal of 1959–1961.6 Congress dramatically strengthened pharmaceutical regulations after each of these events. Thereby whether or not the agency deserves it, the FDA clearly possesses a reputation for protecting public health and consumer safety.

When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my mom or dad how come the doctors don’t get together and make a “miracle” drug that could heal anything and everything. It wasn’t until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother’s diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment.

On a regular basis, consumers like you and I buy items everyday not knowing the total chemicals that are in them. We trust that cosmetic products we buy everyday will be safe, but there are ingredients in our daily products that could or has caused conditions that we don’t know of. In 1820, the very first meeting the U.S had gathered physicians to create regulations on drugs in the United States. The general purpose of The FDA was to have a standard on the drugs that were being imported into the United States. It wasn’t until 1848 the Drug Importation Act was passed by Congress. It required U.S. Customs Service inspection to stop entry of adulterated drugs from overseas. In the middle of 1906, 58 years later the food and drugs act was passed. The original Food and Drugs Act was passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs (FDA).