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Business Law Essay

FDA

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.

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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
buying. In deciding whether to approve new drugs, FDA does not itself do research,
but rather examines the results of studies done by the manufacturer.

The agency must
determine that the new drug produces the benefits its supposed to without causing
side effects that would outweigh the benefits.
In 1992, the U.S. Congress passed the Prescription Drug User Fee Act. This
legislation provided additional resources for FDA through user fees paid by the
pharmaceutical industry, and the agency committed to significant performance goals in
the review and approval of prescription drugs. The goal is to reduce significantly the
time needed for review of new drugs, from the historic average of about to 27 months in
the late 1980s to 12 months for routine drugs and six months for significant new
therapies by 1997.

Whenever there is a problem with drugs, biologics, medical and
radiation-emitting devices, and special nutritional products, they should report
problems to the FDA either directly or via the manufacturer. MedWatch, the FDA
Medical Products Reporting Program, is an initiative designed both to educate all
health professionals about the critical importance of being aware of, monitoring for, and
reporting adverse events and problems to FDA and/or the manufacturer; to ensure that
new safety information is rapidly communicated to the medical community thereby
improving patient care. The purpose of MedWatch program is to enhance the
effectiveness of postmarketing surveillance of medical products as they are used in
clinical practice and to rapidly identify significant health hazards associated with these
products. The program has four goals:
1. To increase awareness of drug and device-induced disease
2. To clarify what should (and should not) be reported to the agency
3.

To make it easier to report by operating a single system for health professionals to
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report adverse events and product problems to the agency
4. To provide regular feedback to the health care community about safety issues
involving medical products.
Consumers should also report to MedWatch when a serious reaction to a
medicine occurs such as: death, life-threatening situation, admission to a hospital or a
longer than expected hospital stay, a permanent disability, a birth defect, or the need
for medical or surgical care to prevent permanent damage.
The FDA also has a department called CDER( Center for Drug Evaluation and
Research). The Center is a consumer watchdog in Americas healthcare system.
CDERs best-known job is to evaluate new drugs before they can be sold.

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The
Centers review new drug applications not only prevents quackery, but it provides
doctors and patients with the information they need to use medication wisely. The
Center makes sure that safe and effective drugs are available to improve the health of
consumers. CDER ensures that prescription and over-the-counter drugs both brand
name and generic, work correctly and that the health .

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Business Law Essay
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FDA 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 safet

2019-07-31 00:16:21
Business Law Essay
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