food and drug administration (FDA)
Consider a study to examine a food and drug administration (FDA)-approved medication for smoking cessation. Discuss the type of study you would use to examine this medication. Justify your selection and indicate the setting, participants, and suggested research question and formal scientific hypotheses (a null and an alternate hypothesis) for your study.
Justify your response using examples and reasoning. Comment on the postings of at least two classmates, explaining whether you agree or disagree with their views.
Discussed the type of study selected to examine an FDA-approved medication for smoking cessation and justified the selection.
Discussed the setting and participants of the study.
Provided a research question with a null and an alternate hypothesis.
Justified answers with appropriate research and reasoning by using examples and references from textbooks, the South University Online Library, and other acceptable references, citing the sources in APA format.
Commented on the postings of at least two classmates by asking questions, providing a point of view with a rationale, challenging a point of the discussion, or making a relationship between two or more points.
S. Food and Drug Administration, because they were in wide use before the 1938 Act (grandfathered in, as it were). (Dunn 1938)
The problem was that Act contained a definition for a "new drug" (one in need of prior approval to market), as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p) (1). The manufacturers set out to establish then, that anything GRAS/GRAE therefore was not a new drug, and needed no FDA blessing.
Many medicines are ancient, and the active ingredients of many drugs on were first introduced before 1938. To make matters worse, between 1938 and 1962, the FDA considered drugs that were identical, related, or similar……
...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. 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 drug proves to be effective and safe, the FDA will approve it. However, the FDA requires some drugs to be furthered studied and require additional clinical trials. When the drug is officially approved, the FDA sends an approval letter to the company- this process may take many years. Some important steps taken for an approval are (2008 Internet Drug News Inc.): Synthesis & Purification - FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects. Animal Testing (short term) - Generally, two or more species (one rodent, one non-rodent) are...
The article reports that LifeScan Inc. and the U.S. Food & Drug Administration (FDA), have notified health care professionals of a voluntery recall of OneTouch SureStep Test Strips, used by diabetics for measuring blood glucose levels at home, because they may provide falsely low glucose level ,...
Formation of the Food and Drug Administration - Direct Essays
Question 4 The Food and Drug Administration (FDA) is a U.S. government agency that regulates (you guessed it) food and drugs for consumer safety. One thing the FDA regulates is the allowable insect parts in various foods. You may be surprised to know that much of the processed food we eat contains insect parts. An example is flour. When wheat is ground into flour, insects that were in the wheat are ground up as well. The mean number of insect parts allowed in 100 grams (about 3 ounces) of wheat flour is 75. If the FDA finds more than this number, they conduct further tests to determine if the flour is too contaminated by insect parts to be fit for human consumption. The FDA takes a random sample of 35 bags of flour for evaluation and finds that they contain an average of 80 insect parts per 100 grams, with a standard deviation of 6.3. Which hypothesis test should be used to determine whether the sample contains more than the allowed 75 insect parts per 100 grams? A. ztest for the population mean B. ttest for the population mean C. ztest for the population proportion D. ttest for the population proportion
An essay or paper on Formation of the Food and Drug Administration
million. Management determined that the individual fair value of the land being used for industrial purposes is $21 million and that the fair value of the buildings and machinery as currently being used (for industrial purposes) is $7 million. 3. Valuation of Intangible Assets The in-process research and development (IPR&D), which is proprietary food freezing technology submitted for Food and Drug Administration (FDA) approval, has a fair value of $15 million.
different regulatory agencies in the United States. In 1997 President Clinton issued food reforms that effected the nation's food supply. Awareness has been raised as a result, and the number of food-related diseases has decreased. The Food and Drug Administration (FDA) and the Center for Disease Control (CDC) are the major regulators of our nation's food supply. Other agencies that play a part in regulating food include: the Environmental Protection Agency (EPA), the Department of Agriculture…
Essay on food and drug administration
?Bureaucracy is a term that frequently has negative connotations for many citizens. But, while Max Weber recognized the efficiency advantages of bureaucracies, he also realized that it carried a price. Discuss a pro and a con of any federal bureaucratic agency. Bureaucracy is an organized structure that is characterized by explicit procedures and regulations. One example of this kind of agency is Food and Drug Administration (FDA). FDA is an Independent Regulatory Agency part of United States Department of Health and Human Services. FDA roles are promoted safety, regulation and supervision in manufactory practices of food, pharmaceutical drugs, vaccines, cosmetics, veterinary products and others. In the other hand, despite the great importance and regulatory processes, also has some bureaucratic pathologies that concern and alarm to several social groups or the community in general.
FDA is characterizing for the rigorous process in manufacturing practices and product development. The safety regulation processes vary widely according by the type of product, risks and the regulatory powers granted to the agency. The positives points of this agency are the regulation of the most important things for the human welfare and quality of life. The most typical regulation is the food and dietary supplements. FDA has the authority to oversee the substances and the complete procedure of all the food that we buy in the supermarket. This brings to everyone the tranquility that all food products are in perfect condition for eating.
The drug production and development are regulated by Center for Drug Evaluation and Research of FDA. These regulation products are the most restricted, and have the most rigorous regulation process. The human medication is one of the most important to note, because only with a bad dose or adding incorrect amount of any substance in the drug, could cause the death of many people because the pha...