Zdrowie i gospodarka · 04/04/2003

Guidance for Industry: How to Use E-mail to Submit a Protocol; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry ( 107) entitled "How to Use E-mail to Submit a Protocol." This guidance describes how sponsors can use e-mail to submit protocols for studies intended to be conducted in support of New Animal Drug Applications (NADAs) to the Center for Veterinary Medicine (CVM). Electronic submission is part of CVM's ongoing initiative to provide a method for paperless submissions. This guidance is intended to implement provisions of the Government Paperwork Elimination Act (GPEA).