Drugs

PADE Violations Found at Vertical Pharmaceuticals

A 10/24-11/1/16 FDA inspection at Vertical Pharmaceuticals, Bridgewater, NJ, found “serious violations” of Postmarketing Adverse Drug Experience reporting requirements, according to a 5/10 Warning Letter from the agency’s New Jersey District Office. Specific violations listed on an FDA-483 included:

failing to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs); and
failing to submit periodic adverse drug experience reports annually for an application that was approved three or more years ago.

“Given the deficiencies, we are concerned that your firm does not have a well-controlled process for the surveillance, receipt, evaluation, and reporting of postmarketing ADEs to FDA,” the letter says. “These deficiencies also raise concerns about your fundamental understanding of the PADE regulations and your firm’s ability to monitor the safety of your drug products.”

Vertical was told to respond with a list of specific steps taken to correct the violations with documentation of each step and a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome