FDAnews Drug Daily Bulletin

FDA Warns Drugmaker on Postmarket Paperwork Problems

May 30, 2017

A New Jersey drugmaker was warned by the FDA for failing to submit paperwork on possible adverse drug experiences for their products.

Vertical Pharmaceuticals, a maker of women’s health and pain management drugs, did not submit any adverse drug experience reports to the FDA since March 2014.

The failures put the Bridgewater, N.J. company more than 913 days late for its 2014 ADE paperwork, more than 672 days late on 2015 reports and more than 50 days late on 2016 ADEs, according to the FDA’s May 10 warning letter.

Vertical also failed to submit periodic adverse drug experience reports for its products, since March 2014. The company also lacked adequate written procedures for dealing with ADEs.

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