FDA Evaluation of Medication Essay

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FDA Evaluation of Medication


The main center within the FDA for the evaluation of medication is known as the Center for Drug Evaluation and Research. The center evaluates all drugs before they are sold. It currently evaluates more than 10,000 drugs that are on the market to ensure that highest standards of those drugs. They also monitor media broadcasts to make sure that messages portrayed are truthful to consumers. Lastly, they provide health care professionals as well as consumer’s information pertaining safest and most effective ways to use drugs. There are three phases that the CDER uses when evaluating drug.
The first phase pertains to the initial investigation of a new human drug. These studies are monitored
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This research is performed after preliminary evidence suggesting effectiveness of the drug has been obtained. The intention of this research is to gather additional information with regard to effectiveness and safety and attempts to be conclusive with answers about the drug as far as benefit/risk issues are concerned. This is also the phase in the drug research process where labels are created and the basic guidelines for definition and public informative information is finalized. These studies may include several hundred to several thousand people.
At any point in time in the research process, CDER can impose a clinical hold if a study is unsafe or if the detail is clearly insufficient in meeting its stated objectives. Great care is taken to ensure that this determination is not made in isolation, but reflects current scientific knowledge, agency experience with the design of clinical trials, and experience with the class of drugs under investigation.
Another thing that the CDER is responsible for doing is approving generic drugs. A generic drug product is one that is comparable to an original drug product and is identified in the FDA's list of approved drug products with therapeutic equivalence evaluations. They are comparable in dosage form, strength, route of administration, quality, performance characteristics and intended use. A term to be familiar with concerning generic drugs is "ANDA."
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