FDA Releases Three Guidance Documents On Filing Electronic Regulatory Submissions

The Food and Drug Administration recently issued a draft guidance, a revised draft guidance and a final guidance for industry on providing regulatory submissions for drugs in electronic format.

Notices announcing the draft and revised draft guidance were published in the Feb. 6 Federal Register (79 Fed. Reg. 7,200) (79 Fed. Reg. 7,201). A notice announcing the final guidance was published in the Feb. 7 Federal Register (79 Fed. Reg. 7,463).

The final guidance, “Providing Regulatory Submissions in Electronic Format—Receipt Date,” describes how the FDA will assign receipt dates to certain submissions to the Center for Drug Evaluation ...