FDAnews Drug Daily Bulletin

Delays in Adverse Event Reporting Bring Warning Letter for Navinta

Oct. 11, 2016

Navinta has received a warning letter from the FDA for violating requirements for postmarketing adverse drug experience (PADE) reporting.

The FDA said its inspection revealed that Navinta had failed to describe how it reviews, evaluates, and reports safety information, including how it identifies the existence of ADEs; how it assesses ADEs for seriousness and expectedness; how it investigates ADEs for missing data elements; how it investigates promptly all ADEs that are both serious and unexpected to obtain additional information about the adverse experiences; how it records all attempts at follow-up; and how it prepares and reports postmarketing safety information.

The inspection, conducted in May, also found Navinta did not submit PADERs to FDA for six approved applications, which is required for each Abbreviated New Drug Application. In the letter the agency stated Navinta’s failure to establish written procedures, submit PADERs, and identify and assess the root causes of these deficiencies raises concerns about its ability to monitor the safety of its drug products.

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