Preview

Food and Drug Administration and Drugs

Better Essays
Open Document
Open Document
1228 Words
Grammar
Grammar
Plagiarism
Plagiarism
Writing
Writing
Score
Score
Food and Drug Administration and Drugs
Business Law
October 11, 2000

The FDA has many responsibilities which include overseeing the production of safe foods and the manufacture of safe and effective drugs and medical devices. The
FDA has responsibility for protecting the rights and safety of patients in the clinical trials of investigation medical products. The FDA also has to review and approve in a timely manner the safety and efficiency of new drugs, biologics, medical devices, and animal drugs. They have to monitor the safety and effectiveness of new medical products after they are marketed and acting on the information collected. The FDA is responsible for seeing that the public has access to truthful and non-misleading product information by: monitoring the promotional activities of drug and device manufacturers, and regulating the labeling of all packaged foods. Science is a big part of the FDA organization. The scientific evidence needed to back up FDAs legal cases is prepared by the agencies 2,100 scientist, including 900 chemist and 300 microbiologist, who work in 40 laboratories in the Washington, D.C., area and around the country. Some of these scientist analyze samples to see, or example if products are contaminated with illegal substances. Other scientist review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents and medical devices. The FDA also operates the National
Center for Toxicological Research. They investigate the biological effects of widely used chemicals. The agency also runs the Engineering and Analytical Center, which test medical devices, radiation-emitting products, and radioactive drugs. Assessing risk, for drugs and medical devices, weighing risks against benefits is at the core of
FDAs public health protection duties. By ensuring that products and producers meet Goins II certain standards, FDA protects consumers and enables them to know what they are

You May Also Find These Documents Helpful

  • Satisfactory Essays

    BIO 275 AP 1

    • 707 Words
    • 2 Pages

    When the testing on animals are finished, pharmaceutical company sends the Investigational New Drug (IND) application to FDA. FDA has time to review the IND application, if any problems are found FDA can put a hold on the drug testing. After pharmaceutical companies receive the permission the testing can be started on humans. If new drug is permitted for testing on humans the company can start to search the volunteers. Testing on humans or clinical trials includes three phases: I, II and III.…

    • 707 Words
    • 2 Pages
    Satisfactory Essays
  • Satisfactory Essays

    Paper

    • 390 Words
    • 2 Pages

    the process and license the process to large pharmaceutical companies for their use in medication…

    • 390 Words
    • 2 Pages
    Satisfactory Essays
  • Powerful Essays

    Clinical Trials: Journal of the Society for Clinical Trials is an international peer reviewed scholarly. The primary aim is the “dissemination and development of knowledge about the design, conduct, analysis, synthesis, history, ethics, regulation and clinical or policy impact of all types of clinical trials and related medical research methodologies.” (Sage Journals, 2013).…

    • 866 Words
    • 4 Pages
    Powerful Essays
  • Good Essays

    A clinical trial is used to evaluate the efficacy and safety of a new drug or a new medical procedure (Merrill, 2013, p. 205) and randomized controlled trials are the most common type of trial conducted in clinical…

    • 977 Words
    • 4 Pages
    Good Essays
  • Good Essays

    The regulations that are in place to oversee the professional and ethical management of these trials will be several countries have developed laws against pharmaceutical companies to prevent their citizens from getting injured. Those several countries have laws that prevent pharmaceutical companies to use their citizens in highly experimental drug trials. Countries such as China and Russia have specifically developed laws to prevent the concerns over illegal trafficking human organs. These also have…

    • 459 Words
    • 2 Pages
    Good Essays
  • Good Essays

    The FDA consists of centers for Biological Evaluation and Research, Drug Evaluation and Research, Food Safety, Radiological Health and Toxicological Health; the FDA’s most visible roles in healthcare are in the approval process for new drugs and medical devices, and in evaluating the efficacy…

    • 302 Words
    • 2 Pages
    Good Essays
  • Satisfactory Essays

    The FDA helps advance public health by speeding up product innovations. The public is informed with science-based in, Puerto Rico formation needed to use medicines, foods and devices to improve their health ( UDHHS, 2010). The FDA approval process not only makes sure that the product's ingredients are safe but also that labels show all ingredients and do not make unverified claims. This has caused the FDA symbol to now become one that consumers trust(Gelinas, 2010).…

    • 265 Words
    • 2 Pages
    Satisfactory Essays
  • Good Essays

    During the preparation phase, they may compile legal statutes, assigned protocols and standard operating procedures. They prepare and participate in monitoring visits, external audits and formal inspections. Nurse researchers are expected to compile and maintain progress notes, source documents and study participant feedback. They must observe and document participant's adverse reactions and unexpected events with regards to consuming experimental pharmaceutical products. Nurse researchers may initiate physician, laboratory, radiology and procedures to test participants and verify their well-being. They may collect participant paperwork, enter the data into software systems and generate report…

    • 540 Words
    • 3 Pages
    Good Essays
  • Good Essays

    Bisphenol a

    • 509 Words
    • 3 Pages

    West Virginia Bureau for Public Heath is ordered under proposed rule with FDA and Food Manufacturing Facilities. The states initiated a program called “Alert” which raises awareness of industry and government representatives. It applies to the farm to table supply chain to decrease the risk of food contamination. The rule is effective now and requires inspections which permits are needed for manufacturing firms. Congress shifted the burden to the industries and placed restrictions on substances deemed risky to the public.…

    • 509 Words
    • 3 Pages
    Good Essays
  • Good Essays

    Cohort Study Essay

    • 436 Words
    • 2 Pages

    A clinical trial is a highly controlled study that evaluates the efficacy and safety of medications or medical devices.…

    • 436 Words
    • 2 Pages
    Good Essays
  • Powerful Essays

    On one hand, modern technology is beneficial in paving the way for the development of new medications. These medications often impact the health conditions of individuals, giving them the opportunity to live longer with certain health conditions that carry a diagnosis of a shorter life expectancy timeline. The medical innovations do not come without a cost, which is part of the reason why prescription medication grows increasingly more expensive each day.…

    • 1516 Words
    • 7 Pages
    Powerful Essays
  • Satisfactory Essays

    The entire proposal related to the human subject must be submitted for review for their scientific and ethical acceptability to one or more ethical and scientific review committee. Before the researcher go through, he has to receive the approval or clearance. Monitoring the progress of the study in the course of the research for further reviews has to be made by ethical committee.…

    • 349 Words
    • 2 Pages
    Satisfactory Essays
  • Good Essays

    For example, frequent cancer screenings can be beneficial to only a few who are susceptible to it, while is a lot of investment on those who are not really endangered, similarly not prescribing drugs to patients with high cholesterol might increase their chances of a coronary heart disease leading to a more expensive treatment. There cannot be one perfect fit to everybody and thus weighing the importance of preventive measure specific to a population is very important. The two terms that usually comes to mind when this topic is discussed are “Cost-saving” and “Cost-effectiveness” and are often confused with each other. Any preventive measure that reduces cost is cost saving, for example childhood immunizations. On the other hand, if the benefits of a preventive measure greatly outweigh the costs, then it is cost cost-effective, even if it does not really save dollars in the short term. Cost-effectiveness is expressed as ratio of incremental costs to incremental benefits. A low ratio means the method is cost-effective while a high ratio means the method is expensive with little benefits. These benefits are described in terms of number of quality adjusted life years (QALYs) saved, which considers both the length of life and quality of life. Factors which…

    • 687 Words
    • 3 Pages
    Good Essays
  • Good Essays

    Formed in 1906, the Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. One of the 6 centers making up the FDA is the Center for Food Safety and Applied Nutrition (CFSAN) which works to assure that the food supply is safe, sanitary, wholesome, and honestly labeled. In 1938 the Tugwell bill signed by Teddy Roosevelt, are you sure it was Teddy?! stated that food standards were required to be set up when needed "to promote honesty and fair dealing in the interest of consumers.” This is still the principal foundation of the CFSAN today (U.S. Food and Drug Administration).…

    • 3063 Words
    • 13 Pages
    Good Essays
  • Good Essays

    Pharmacist

    • 620 Words
    • 3 Pages

    I am choosing to define Pharmacist because it is something that I want to study and I want to give people some information of what a pharmacist is. A person who has studied chemistry and health, and has earned a degree is called a pharmacist. This person can get a career that will allow them to mix and prepare any kind of medicine that is needed. They can also help people find the right medication for them or send them to a doctor to get the prescription they need. Pharmacists study to prepare the medicine we need for our health; process, negation, and cause and effect are three methods that can help define a pharmacist.…

    • 620 Words
    • 3 Pages
    Good Essays