Drug Product Approval in the United States and International Harmonization

Any person or organization who intends to bring a drug product to market in the United States must, by law, first submit a marketing application to the US Food and Drug Administration (FDA). The FDA is responsible for reviewing each marketing application and determining whether the applicant or sponsor has provided adequate evidence of safety, efficacy, and quality to warrant marketing approval. FDA oversight of drug products extends, as described in chapter 21 of the Code of Federal Regulations and guidance documents, over the lifecycle of marketed drug products and to all relevant drug manufacturing activities and facilities. This chapter presents a current overview of the drug approval process as it pertains to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) in the context of FDA.