Vertical Pharmaceuticals Violated FDA Drug Reporting Requirements

Vertical Pharmaceuticals Inc. isn’t submitting all required reports on adverse drug experiences to the FDA, according to a recent warning letter.

The Food and Drug Administration said in a letter posted online May 16 that it found serious violations of postmarketing adverse drug experience (PADE) reporting requirements during a 2016 inspection of the Bridgewater, N.J.-based company. Vertical makes women’s health products that treat menopause symptoms and digestive problems as well as pain management products.

Warning letters are a good indication of the FDA’s enforcement priorities.

Specific Violations

The FDA said the company failed to submit required adverse drug experience ...