Check Your Understanding

U.S. Food and Drug Administration
Protecting and Promoting Your Health

Small Business Assistance
Center for Drug Evaluation and Research

FDA eCTD Overview and Submission WBT

Transmitting Electronic Submissions to CDER

USER INSTRUCTIONS:

Select the correct answer and then click the Check Answer button.

Page 12 of 13

	A.	Three electronic copies are required.
	B.	FDA recommends that the sponsor submit a paper copy of the cover letter including the contact information and FDA form, in case the media proves to be unreadable.
	C.	The physical media should be sent directly to the FDA review division responsible for reviewing the application.
	D.	Sponsors cannot submit via physical media.