FDA Evaluation of Medication Essay -- essays research papers

FDA Evaluation of Medication Introduction 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 very closely and are sometimes conducted in patients, but are usually conducted most frequently with healthy volunteers. They are designed to determine the metabolic and pharmacological reactions of the drug in humans, and possible side effects of the drug in proportion to dosage. Another reason for this phase is to gain some preliminary evidence on the effectiveness of the drug. During this phase of the research, there should be significant knowledge obtained with regard to the effects of the drug in order to have a second phase that is valid and more in depth. The first phase of study also evaluates the way the drug metabolizes and the potential of activity to affect the performance of the drug. When doing a phase one study of a drug, the number of subjects varies significantly. However, in most phase one studies the number of subjects participating in the study range from twenty to eighty. In the first phase of studies on a drug, the CDER can place a hold on the study for many reasons. Some of the reason may include safety reasons or ethical reasons pertaining to the subjects. The second phase includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase two studies often the most well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people. The third phase of drug research is much expanded... ...s categorized through the rulemaking process as follows: †¢Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Category I - generally recognized as safe and effective and not misbranded. †¢Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Category II - not generally recognized as safe and effective or is misbranded. †¢Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Category III - insufficient data available to permit classification. This category allows a manufacturer an opportunity to show that the ingredients in a product are effective, and, if they are not, to reformulate or appropriately re-label the product. CDER also oversees OTC drug labeling because the safety and effectiveness of OTC drug products depend not only on the ingredients but also on clear and truthful labeling that can be understood by consumers. The CDER is always responsible to inform the producer why the product did not meet the standards set forth by the FDA. If the producer questions or disagrees with the results of the CDER, there are ways in which to approach the issue to have it evaluated further. While the CDER is the final authority on whether or not a product is marketed, they are fair in their evaluation and decisions with regard to products.