Zdrowie i gospodarka · 28/01/1999

Guidance for Industry on General Considerations for Providing Regulatory Submissions in Electronic Format; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--General Considerations.'' This guidance discusses issues common to all submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). A notice of availability for a related guidance entitled ``Providing Regulatory Submissions in Electronic Format--NDA's'' is being published elsewhere in this issue of the Federal Register. Both guidances are part of a series of guidances being developed by the agency to assist applicants who wish to make regulatory submissions in electronic format. Guidances addressing other submission types, such as biologics license applications, abbreviated new drug applications (ANDA's), and investigational new drug applications (IND's), are being developed and will be issued in the future. Although submissions in electronic format are voluntary, the agency encourages them as a way to improve the efficiency of handling and reviewing documents and data.