Key Drug Facts Often Left off FDA Labels

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Fnen94

Business Finance

Description

Write a paper about this topic, you should include (click on the link)

first, a describing of the story at beginning

second, analysis

third, criticize

fourth, give two opinion from a project manager point of view

fifth, the FDA point of view and perspective

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Explanation & Answer

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Introduction
Labelling is defined as all labels and any other printed, written or graphic matter on an article,
wrappers or container in the United States Federal Food, Drug, and Cosmetic Act. Through
registrar corp companies can modify their products such as food, medical devices, medical,
drugs, and cosmetics labeling hence ensuring that they comply with the FDA regulations.
Registrar Corp will revise the graphic labels of the various products, and then the organization
will produce a report which entails regulations, warning letters, compliance guides and any other
documents for guidance that necessitated the revisions. The FDA requires that all drugs labeling
is in Structured Product Labelling format using Extensible Markup Language.
Despite this regulations, drug labeling doesn’t entail the full scope of the side effects associated
with the use of various drugs. In a research conducted by the New England Journal of Medicine
revealed that found that labels don’t include the full side effects that are associated with the use
of drugs. Patients that use the counter drugs have little knowledge of some of the side effects that
may arise from consumptions of drugs since this effects aren’t stipulated in the labels(O'Reilly,
James & Amy). Therefore unknowingly one might end up with severe side effects some very
critical from the use of some drugs. This affects those also on prescribed medications since even
the doctors might also not fully understand the side effects of some drugs that they provide their
patients with since the i...


Anonymous
Really useful study material!

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