The process of reviewing new medications to ensure they are safe and effective makes use of many epidemiological methods. The Food and Drug Administration is involved heavily in this regulation and is required to ensure rigorous testing is done before medications are released to the general public.
For the first part of this assignment, review the following website, which details the FDA process:
Next, watch television or listen to the radio and write down the names of two new medications being advertised.
- Research these medications and complete the chart below on their development.
When filling out the chart, use complete sentences; each box should contain at least one full paragraph of information. You must include support from the required readings, as well as at least one outside source. Use the WCU Library to find scholarly sources that support your paper.
Due: Sunday, 11:59 p.m. (Pacific time)
Points possible: 100
Expert Solution Preview
Introduction:
This assignment focuses on the process of reviewing new medications and the role of the Food and Drug Administration (FDA) in ensuring their safety and efficacy. Students are instructed to review the FDA website, identify two new medications being advertised, and complete a chart on their development using scholarly sources as supporting evidence.
Answer:
The FDA plays a critical role in ensuring that new medications are safe and effective before being released to the general public. The FDA approval process involves several stages, including preclinical testing, clinical trials, and post-market surveillance. During preclinical testing, drugs are tested in animal models to determine their safety and efficacy. If the results of preclinical testing are promising, the drug moves on to clinical trials, which involve testing in human subjects. Clinical trials are usually conducted in three phases, and involve progressively larger groups of participants. If a drug successfully passes through all phases of clinical trials, it can be submitted for FDA approval.
Using this knowledge, students are instructed to identify two new medications being advertised and complete a chart on their development. The chart includes information on the drug’s name, indications, development stages, FDA approval, and any relevant safety concerns. In completing the chart, students are required to use at least one outside source, in addition to the class readings, to support their analysis.
Overall, this assignment provides students with an opportunity to deepen their understanding of the FDA approval process and its role in ensuring the safety and efficacy of new medications. By completing the chart, students develop skills in research, critical thinking, and scientific writing, which are essential for success in the field of medicine.