Overview: In the calendar year 2015, the pharmaceutical industry witnessed the largest number of Food and Drug Administration (FDA) prescription drug approvals in the past decade. The FDA's Center for Drug Evaluation and Research played a valuable and key role in bringing these drugs to market.Why should you Attend: By definition, drug development is the process of bringing a new pharmaceutical drug product to market once a lead compound has been identified through the process of drug discovery. Although the drug approval process has its rewards, sponsors, clinical investigators and regulatory professional need to understand the complete process, resources and guideline available to assist them in all phases of clinical development.This presentation on "FDA New Drug Approval Process" will provide those resources and guidelines as well as the regulatory requirements to be compliant with all regulatory agencies. This webinar will highlight the preclinical and clinical investigations, responsibilities of the clinical investigators and the sponsors. Above all it will provide details into the entire New Drug Application (NDA) process and discuss the drug safety and efficacy data that is required to submit the NDA. Additionally the monitoring and reporting that is required during the clinical trials will be discussed. Areas Covered in the Session:Federal Food, Drug and Cosmetic ActBasic goals of preclinical investigationsCode of Federal RegulationsResponsibilities and Importance of the Institutional Review BoardsUnderstand the FDA drug development requirementsWho Will Benefit:Regulatory Affairs PersonnelCompliance professionalsQuality PersonnelClinical PersonnelResearch Personnel