Zdrowie i gospodarka · 18.06.2018
Technical Specifications for Electronic Submissions; Establishment of a Public Docket
The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency's publication of technical specifications, which explain, clarify, and define the specific use of data standards in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This docket is intended for general comments related to technical specifications that are not specific to documents or issues that are the subject of other dockets, or for comments specific to electronic submission guidances.