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food& drug administration. how to get fda cirtificateof a microbiology graguate student. plz suggest me any way.

2006-09-24 17:33:38 · 7 answers · asked by Anonymous in Science & Mathematics Medicine

7 answers

fda is the food and drug admin. to get the certificate you have to be in an acredited program

2006-09-25 05:24:37 · answer #1 · answered by shiara_blade 6 · 0 0

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and blood products in the United States.

The drug approval process

The FDA is charged with the task of approving or rejecting drugs that pharmaceutical companies want to market. Critics of the FDA's handling of this task generally fall into two groups. The first group claims that the approval process is too extensive, and keeps vital drugs off the market longer than is necessary. The second group argues that the process fails to properly screen for drugs with dangerous side-effects.

Dexfenfluramine, troglitazone and rofecoxib (trade name Vioxx) are a few recent, high-profile examples of drugs approved by the FDA which later caused harm to patients. Dexfenfluramine was a diet drug which had been available outside the United States for several years. Critics charge that the FDA failed to pay attention to safety concerns raised by post-marketing data from abroad, which indicated an increased risk of pulmonary hypertension.

Troglitazone is a diabetes drug that was also available abroad at the time the FDA approved it. Like dexfenfluramine, post-marketing safety data indicated that the drug had dangerous side-effects (in this case, liver failure). The drug was approved over the objections of several FDA reviewers, and was later pulled from the market.

In the case of Vioxx, a study indicated that a group taking the drug had four times the risk of heart attacks when compared to another group of patients taking another anti-inflammatory, naproxen. The FDA was aware of this study, but the manufacturer (Merck) argued that naproxene had aspirin-like protective effects. The FDA accepted this reasoning. After numerous lawsuits against Merck, the manufacturer voluntarily withdrew it from the market in 2004.

To avoid such mistakes, the FDA ensures that newly approved drugs have passed vigorous testing, which includes animal testing, clinical trials of healthy individuals, and clinical trials of individuals suffering from the disease the drug is meant to treat. The FDA also verifies safety, quality, efficacy, along with drug interactions, and how various drugs may work depending on age, race, and sex. Critics argue that this process is long, tedious, and costly, and dramatically lengthens the time it takes effective drugs to hit the market.

The FDA does fast-track new treatments for serious diseases where no treatment currently exists[2]. This rule attempts to address situations where the risks of keeping lifesaving drugs off the market outweigh the risks the drugs might pose to consumers.

http://en.wikipedia.org/wiki/Fda#The_drug_approval_process

2006-09-28 05:17:36 · answer #2 · answered by danielpsw 5 · 0 0

Federal drug administration

2006-09-25 13:07:40 · answer #3 · answered by slickcut 5 · 0 0

It is Federal Government employment although some states offer similar spots in Environmental regultion. Go to FDA.gov

2006-09-25 03:59:22 · answer #4 · answered by Intersect 4 · 0 0

You are not a graduate of anything, much less microbiology...
You can't even speak English...

2006-09-25 00:38:46 · answer #5 · answered by Anonymous · 0 0

You should do some googling. Also, you must also use spell check if you can't spell, it would make it so much easier for the reader. Good luck.

2006-09-28 02:43:31 · answer #6 · answered by bobbie e 3 · 0 0

Yep! N i is a publik skool gradiate!

2006-09-25 00:42:24 · answer #7 · answered by Yaakov 6 · 0 0

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