Drugs

PADE Reporting Violations at STI Pharma

A 7/11-7/21 FDA inspection at STI Pharma, Langhorne, PA, found serious violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, according to an 11/21 Warning Letter from the agency’s Philadelphia District Office. Specific violations included failing to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. The letter says that STI does not have any written procedures that describe how it, and the contractors acting on its behalf, comply with PADE regulations.

“Given your reliance on contractors to carry out PADE activities,” FDA says, “we are concerned about your firm’s fundamental understanding and implementation of PADE regulations, including how they relate to your use of contractors. As the application holders of two NDAs and five ANDAs, you are ultimately responsible for ensuring compliance with the [Federal Food, Drug, and Cosmetics] act and the PADE reporting regulations. The lack of written procedures and the examples of failing to report safety information to FDA in a complete, accurate, and timely manner raise concerns about your firm’s ability to assess the safety of your drug products.”

The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, 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