Drugs

Corporate Compliance Guidance Tracks GMP: Attorney

An updated Justice Department guidance document reinforces the importance of a robust, well-designed, and effective corporate compliance program in the department’s determination of whether to prosecute, impose monetary penalties, and require compliance obligations on a company accused of misconduct. Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the guidance expands on the types of questions prosecutors should be asking to evaluate a company’s compliance program.

Questions are in these three main categories, she says: (1) is the compliance program well designed; (2) is the program being applied earnestly and in good faith (implemented effectively); and (3) does the compliance program work in practice.

“Notably,” Walsh writes, “these same questions are those that drug and device companies routinely ask in the context of evaluating complaints about the company’s products. The Quality System Regulation requires medical device companies to establish procedures to implement corrective and preventive action. These procedures must include an investigation of the cause of the issue, actions to correct and prevent recurrence of the issue, validation to ensure the actions are effective, and management oversight and review. Similar requirements are imposed on drug manufacturers as part of complaint handling and adverse event reporting. Thus, a framework for addressing compliance issues should be very familiar to pharma and device companies.”

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