Pharmaceutical companies discover, develop, produce, and markets drugs or pharmaceutical drugs for use as a medication to be administered or self-administrated to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal with genetic or brand medications and medical devices. In the Unites States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves the submission of an investigational new drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficiency in the intended patient population. Following the successful completion of phase III a new drug, we submitted it to FDA. The FDA reviews the data and if the product is seen as having a benefit-risk assessment, approval to market the product in the US is granted.