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The website cannot function properly without these cookies. The Agency looks for evidence of fabrication, manipulation, or withholding of data. The review team issues a recommendation, and a senior FDA official makes a decision.
In cases where FDA determines that a drug has been shown to be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information. Often, though, remaining issues need to be resolved before the drug can be approved for marketing.
Sometimes FDA requires the developer to address questions based on existing data. In other cases, FDA requires additional studies. At this point, the developer can decide whether or not to continue further development. If a developer disagrees with an FDA decision, there are mechanisms for formal appeal.
Sometimes, though, questions arise that require additional consideration. This goes to say that, a drug that is developed in a scientific laboratory does not escape evaluation by FDA. Clinical research on drugs is conducted by research as well as non research scientists. The metabolism of the drug and how this drug is excreted is tested in the first phase. It is tested on healthy individuals who volunteer this testing. When the first phase does not show toxicity, it reaches the second phase of testing.
It is tested for its effectiveness to cure the disease it is designed to cure. Once there is an evidence of its positive effect, the FDA approves the drug, and meeting is conducted with the sponsors for large scale production. Data for marketing of the drug is gathered before marketing the drug.
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