Vertical Pharmaceutical Sits on Adverse Experience Reports

An FDA inspection of New Jersey-based Vertical Pharmaceuticals Inc. last fall found serious violations of the FDCA’s requirements for reporting adverse drug experiences, according to a letter dated May 10.
It submitted the reports after the inspection, one of which was more than 2 1/2 years late, according to the FDA. The reports must be sent to the FDA within 15 business days of a company’s receipt of an adverse drug experience.

These failures raise serious concerns about the company’s ability to monitor the safety profile of its products, and whether it understands ADE reporting regulations, the FDA said.

https://www.law360.com/articles/924522/fda-warning-wire-drug-ingredients-in-soda-bottles

 

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Any news on RVL?

 

yea there’s already generics