Zdrowie i gospodarka · 28.10.1994
Guidance Manual for Computer Assisted New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the revised guidance manual entitled ``Computer Assisted New Drug Application (CANDA) Guidance Manual.'' This manual was developed by FDA's Center for Drug Evaluation and Research (CDER), in conjunction with the pharmaceutical industry. The manual provides guidance for the submission of computer assisted new drug applications (CANDA's), investigational new drug applications (IND's), and abbreviated new drug applications (ANDA's).