Devices

Help Industry with ‘Bad Labs’: Post

Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz and attorney Allyson Mullen say FDA should follow its 2/20 letter to the medical device industry urging companies to be aware of issues with fraudulent laboratory data with “practical guidance to help firms establish and maintain data integrity across the total product lifecycle.” In a post on their company’s FDA Law Blog, Lenz and Mullen say the agency letter provided little information to guide industry conduct. “While the title of the letter refers to ‘fraudulent’ data,’” they write, “the rest of the letter does not explain the nature of the allegedly fraudulent activities that could assist industry in identifying bad labs.”

Lenz and Mullen say FDA must be transparent with industry as to how the issue will be handled for pending and cleared submissions.

“The sponsors are almost always victims that had no intention to deceive the agency,” they conclude. “Unless or until FDA can provide actionable guidance on how to avoid being deceived and/or how to manage the issue, if it is uncovered, we urge FDA to give sponsors the benefit of the doubt and work with them to resolve the issue.”

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