Supporting Pharmaceutical Studies for FDA Submissions: Diversifying the Drug Monitoring Laboratory (Tdm Conference‪)‬

There is a rigorous review process associated with bringing a new pharmaceutical product to the consumer market in the US. Introduction of a new drug or a new clinical application for a drug requires demonstration to the US Food and Drug Administration (FDA) that a beneficial effect can be clearly associated with that drug; side effects and toxicities must be declared with statements from medical experts, indicating that the clinical benefits outweigh any known detrimental effects; and the pharmacokinetics of the drug must be defined as technology allows. The process of filing with the FDA to obtain approval to market the drug is known as a New Drug Application (NDA). (1) For generic drugs, the process of applying for approval to market is described as an Abbreviated New Drug Application (ANDA), "abbreviated" in that the application does not require information supporting the clinical efficacy because that has already been demonstrated. Information describing the pharmacokinetic characteristics of the proposed generic form of the drug must be submitted to document that the generic form is biologically equivalent to the proprietary product.