The Food And Drug Administration

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

Institutional Powers have always affected my life in many ways. The main institutional power that control both positive and negative consequences of my life would be the FDA the Food and Drug Administration. The first way they control my life is they regulate all human and veterinary drugs in our country. Second, the FDA is responsible for protecting the public health and products. Lastly, they supply and control the entire United States Food supply. I believe that this specific governmental institutional power is 100% the authority over my life. The FDA needs to care more about the general health of the public and take into consideration how they play a major factor in the health of our bodies, minds, and environment as well.

To begin we will be discussing the federal Agency called food and drugs administration better known as FDA. As a federal agency the FDA has a lot of responsibility with regulating food and drug safety. The FDA works to provide good medical services and insured food products. The FDA works to support our country so that we can live peacefully and healthily but they don't just stop there they wish to help other countries and have even expanded there work to other countries such as China and Costa Rica. So the FDA holds a big part in our society and we as citizens need to be aware of this.

The FDA plays a very prominent role in everyone’s lives whether people realize it or not. The role of the Food and Drug Administration is to put regulations in place in order to keep the population safe from disease, like ones that come from contamination of meat in slaughterhouses. The problem of contamination of meat often originates from a lack of cleanliness in slaughterhouses and stockyards, which is something that stockyards and slaughterhouses lacked much of in the book Devil in the White City.

The use of tobacco is a very controversial topic here in the United States. The harmful side effects of tobacco are well known and consequently, many believe that it should be outlawed. Though this has not yet occurred, constant regulations on the industry and

There are many aspects of the Food and Drug Administration’s current regulations that are of great concern to many. For instance, the regulation of GMOs, or genetically modified organisms, is a largely debated subject, especially in relation to genetically modified food, or GM food. As described by nongmoproject.com, “GMOs, or “genetically modified organisms,” are plants or animals that have been genetically engineered with DNA from bacteria, viruses, or other plants and animals. These experimental combinations of genes from different species cannot occur in nature or in traditional crossbreeding.” Most of the American population may not even realize this, but according to nongmoproject.com: “In the U.S., GMOs are in as much as 80% of

PrEP treatment is taken in the form of a pill, called Truvada. Truvada is a combination of two HIV medications (tenofovir and emtricitabine). Truvadais a fairly new drug. It was approved for human use by the U.S. Food and Drug Administration (FDA) and allowed clinical practice guidelines for usage in the America by the U.S. Public Health Service and the Centers for Disease Control and Prevention (CDC) in May 2014. In order for Truvada to be effective, users of PrEP must adhere to taking one pill every day. They must also meet with their healthcare provider every three months to follow up. It is imperative that people who have been exposed to HIV by way of intravenous drugs use or sex seek PrEP to prevent the virus from spreading through the body.

The Orthotics field is often associated with upper limb orthoses, such as an airplane splint, lower limb orthoses, such as AFOs (ankle-foot orthosis) and FOs (foot orthosis), or spinal orthoses. However, there are also orthotic devices for other areas of the body, like the head—cranial helmets. Also referred to as cranial bands, “helmet molding therapy, or cranial orthosis, is a type of treatment where an infant is fitted with a special helmet to correct the shape of the skull” (Kieffer). Cranial helmets resemble bicycle helmets in appearance as displayed by Figure 1. The Food and Drug Administration (FDA) regulate a large portion of cranial helmets, similar to other medical devices. Under the FDA, cranial orthoses are categorized as a Class II medical device. A “class II devices represent a medium risk category for which FDA establishes that additional special controls are needed to ensure safety and efficacy. Examples of class II devices would include sutures and bone drills” (Littlefield). Cranial Helmets are designed and/or fitted by an Orthotist (an allied health practitioner). In the majority of cases, cranial helmets are constructed out of various plastic polymers with a multitude of decorative patterns and colors.

As senior advisor of the Food and Drug Administration (FDA), I understand that you must have thousand of proposals being addressed to you everyday. I also understand that the FDA is responsible for tests that use dogs, primates and other species as test subjects to meet legal safety requirements. (Navs.org) At the same time, I, and millions of other people believe that the laws on animal experimentation need to be reviewed. This is a topic that has been given a lot of attention for the past decade. Everyday, hundreds of news articles are written arguing about whether or not animal experimentation should be stopped. Many of these articles reveal the pain and

On December 1, 2014 the U.S Food and Drug Administration (FDA) established two new rules requiring menu labeling and vending machine labeling. What does this mean exactly, well when it comes to menu labeling any establishment that has 20 or more chains are now required to list the calorie information on their menus or menu boards. This not only includes sit-down restaurants but also drive-through windows and takeout foods. They also established another rule for vending machines which requires all owners or operators with 20 or more vending machines to display calorie information as well. According to the FDA “Americans eat and drink about one-third of their calories away from home. Making calorie information available will help consumers make informed choices for themselves and their families”.

Who loves to drink medicine all the times? Many people would want to hate drug companies because those drug companies can insanely make profit off of expensive medicine that people cannot live without today. Big pharmaceutical is a vast bunch of business companies that are motivated to basically make money and product. Majority of this business of drugs and medical devices are manufactured by bringing billions of profits where it leaves their consumers with harmful side effects such as health suffering experiences (Big Pharma Manufacturers, 2016, p.1). Big pharmaceutical is just a well-known influence over the prescriptions drug and medical device markets all around the nation; even in the United State, the industry gives numerous “annual budget of the U.S. Food and Drug Administration (FDA) (Big Pharma Manufacturers, 2016, p.1).” Also, the industry wants to show its power within the political and social great impacts upon the “nation’s governments and agencies, its health care systems, its doctors and hospitals, as well as the psyche of the American people (Big Pharma Manufacturers, 2016, p.1).” To tackle this issue, around 1900’s, there were great medical solutions to many illnesses, whereas the big pharmaceutical market became so global in today’s economy (Big Pharma Manufacturers, 2016, p.1).

Since 1979, the Food and Drug Administration (FDA) has required that all prescription drugs have a shelf life (or expiration date) indicated directly on the container label. Similar requirements are in place in the European Union and around the world (1).

The U.S Food and Drug Administration (USFDA) is the government agency responsible for ensuring the safety and efficacy of drugs and medical devices in the USA. The two legislative acts that are the main source of the FDA’s authority are:

On July 16, 2012, the Food and Drug Administration (FDA) approved the use of Truvada, the first drug approved for reducing the risk of contracting an HIV infection in uninfected individuals ("FDA Approves First Drug for Reducing the Risk of Sexually Acquired HIV Infection"). Truvada is made up of two drugs, emtricitabine and tenofovir, that work by blocking an enzyme called reverse transcriptase, which HIV uses to copy its genetic material in order to reproduce. Truvada has been approved for the treatment of HIV in infected individuals for about ten years. However, scientific experiments have shown that it can be used to protect uninfected people who are at high-risk for acquiring the virus by taking the drug daily, before and after exposure (Costa-Roberts). Extensive research involving Truvada have been conducted over the years but the results have been interpreted differently among the HIV and AIDS society. While the need for a cure or vaccine for HIV is not commonly refuted, the controversy surrounding the daily use of Truvada as a preventive measure against AIDS center around effectiveness and commitment.

Once I have secured a meeting with Get Well Drugs, I will present the following questions based on FDA’s Center for Drug Evaluation and Research (CDER) guidelines for the development and approval for drugs. CDER’s job is to also determine the efficacy of drugs, prevent quackery and provide information about the medicine to doctors and patients (Drugs, 2014).