Guidance for Industry and FDA Staff Providing Regulatory Submissions in Electronic Format — General Considerations. Document dated Oct 22, 2003. This guidance focuses on use of pdf files. It provides many specific requests in construction of the pdf for suitability for electronic submissions. These include resolutions, pagination, preference for digital instead of scanned source documents....Read More
Upcoming Public Courses
No public courses are planned at this time.
If you would like to discuss a private, onsite course, please fill out the form below.