Regulatory Submission Unit Type

A unique identifier assigned to a submittion by the regulatory authority. Submission serial number, volume number, electronic folder, or file name are…

A particular category of a regulatory submission regarded as having particular characteristics, purposes, and causing different regulatory requests.

Physical media documenting the date and time when a regulatory submission is received in the FDA Document Room. This is an official…

A date on the submission form or cover letter, whichever is the latest.

An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of…

The Regulatory sub-domain is intended for those involved in the creation and review of submissions to regulatory authorities. The majority of business…