FDA Releases Draft Guidance titled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications”- Drug Information Update

Today, the U.S. Food and Drug Administration (FDA) published a draft guidance that will bring clarity to the drug development process as it relates to threshold analyses and human factors submissions.  This draft guidance, “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications” will assist sponsors of drug and biological products that are the subject of an investigational new drug application (IND), a new drug application (NDA), a biologics license application (BLA) and certain drug-device combination products submitted in Abbreviated New Drug Applications (ANDAs), to streamline the submission process, thereby helping to increase the efficiency of the review process.

The FDA looks forward to receiving public comment on this draft guidance through the established docket (enter Docket No. FDA-2018-D-3275).