Writen Assignment 1 Essay

Submitted By sallyb10
Words: 675
Pages: 3

The development of drugs is very important in our world. What would happen if there weren’t a step-by-step process to make sure that drugs were safe and effective? Everything would pretty much fall apart. The FDA has come up with a simple five-step pathway that all drugs go through in order to be safe and efficient. This essay will describe how and what is done. The first step in this process is discovery/concept. During the drug development there is discovery and development going on. During the discovery portion, researchers discover new drugs through new insights, many tests, existing treatments and new technologies. There are new insights in a disease process that allows researchers to make a product or us to stop and reverse the effects. Second many test of molecular compound find it beneficial effects against large number of diseases. And last new technologies, which are used to provide new ways to target medical products for within the body. The second part in the process of discovery and concept is development. When researchers make or identify a compound for development they make experiments to make information on how it's absorbed distributed metabolized an excreted. They also get information on its potential benefits and mechanisms of action, the correct dosage, the best way to give the drug like mouth or injection, side effects, how to effects different groups of people depending on gender, race or ethnicity, interaction with other drugs and treatments and effectiveness with other/same drugs. Next in this step is the device discovery and concept. First the FDA classifies the medical devices. They usually can change depending on the results in the lab. There are three different classes that they can be classified into. The first one is general controls, the second one is general controls with special controls, and the third one is general controls and premarket approval. Going back to class one these are devices having the least amount of risk for consumers. Examples of general controls are good manufacturing practices, standards and reporting adverse events to FDA, registration and general record keeping requirements. Class to our devices that are similar to cost one devices but they are at a little bit of a more risk to consumers. Some special controls include labeling requirements device specific mandatory performance standards and device specific testing requirements. The last class which is the general controls and premarket approval are usually the ones that support life, are implanted in the body or have a potential risk of causing unnecessary and illness or injury. These can include pacemakers, breast implants, and HIV