Zdrowie i gospodarka · 22/10/2003

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-General Considerations; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--General Considerations." The draft guidance discusses general issues common to all types of electronic regulatory submissions and updates the guidance of the same name, issued in January 1999. The update now includes information for the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM) and reflects advances in technology as well as lessons learned from experience with electronic submissions received over the past several years.