Food and Drug Administration Coursework Assignment

Food and Drug Administration
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Introduction
TRIP #1
The Food and Drug Administration remain to be the oldest agency in the U.S that is concerned with consumer protection comprehensively. It began way back in the around 1848 when Lewis Caleb Beck was appointed to conduct a chemical analysis of agricultural products this department was inherited by the new Department of Agriculture in 1862. (Administration, 2005) It was not initially known by its present until 1930. The modern FDA's regulatory functions started when the pure food and drug act was passed in 1906 which did not allow interstate commerce in adulterated foods as well as misbranded drugs. The people who have been on the forefront to ensure that this law is enforced are the likes of Washington Wile, the chief chemist of the Bureau of Chemistry in that particular division of Agriculture. The most interesting bit about this history is that the consumer of food and drugs never knew that they needed protection, and therefore there was a need for someone to provide basic elements of this protection that was unknown to them (Contributor, 2016).
Medical review is basically for understanding the process and trials that drugs go through, before they reach local pharmacies, drugs keep undergoing review now and then and there are many evolutions of drugs. There have been new initiatives, new program areas that have been introduced in the new century and are meant to promote and protect the health of the inhabitants of America (Kiliany, 2004). The Congress not only ensured that food and drinks are tested but also worked toward ensuring that drugs were effective as well. The center of biological evaluation and research is responsible for reviewing products that come from living sources animal, plants, humans and micro-organisms it monitors all human drugs once they are on the market, and they also can remove products which could have some anomalies in the process of manufacturing. It should be noted that it is not the sole responsibility of FDA to develop new drugs, but they play a major role in controlling the development and also monitor how it is conducted in clinical trials in partnership with the industry (Marks, 2016).
TRIP #2
The CDER ensures that drugs that are sold in the market adhere to the set standards. CDER does not test drugs ensure that they are safe and effective, but the center's office of testing and research does some research in the areas concerning quality, safety, and effectiveness of the drug. (Office, 2012) When a company develops a new drug and then submits it into the market; it is its sole responsibility to test it and later give evidence of the safety and effectiveness of the drug to the CDER. Then a team from this department will review the data or samples provided and then approve it to be released to the market.
All possible side effects of drugs cannot be entirely determined during the pre-approval stage; therefore there is a need for post-marketing surveillance of the drug. FDA keeps a system that conducts post-marketing surveillance and programs that assess the risks involved with the drugs in the market (Sullivan, 2012). This helps to check any risks that were not detected during the approval process. This is the information and data that the agency uses to update drug labeling, development of new drugs and in very rare cases, reevaluate the decision to approval and market the drug. The agency also has a program that reaches out to those that provide healthcare to educate them on their duties on assisting the agency in providing truthful information during advertising and avoiding misleading information...