Devices

Q-Submission Guide ‘Step in the Wrong Direction’: Expert

Senior medical device regulation expert Lisa Baumhardt (Hyman, Phelps & McNamara) says aspects of a recent FDA draft guidance on Requests for Feedback and Meetings for Medical Device Submission: The Q-Submission Program “could have a negative impact on future pre-submissions.” Writing in her firm’s FDA Law Blog, Baumhardt says the draft’s attempt to clarify when a sponsor’s question may be more appropriate for more informal communication “hardly provides clarification and seems to limit the topics that could utilize this method of feedback.”

Baumhardt says she hopes the final guidance provides more clarity on the use of informal interactions with the agency as a method of getting feedback. “We consider the focus on limiting the number of questions that can be addressed in any one pre-submission and the impact that will have on development timelines to be a step in the wrong direction,” she concludes. “The approach to submitting a pre-submission with a limited number of questions and following with additional pre-submission supplements to get feedback and alignment with the agency on a variety of topics does not align with helping ensure timely access to new medical devices.”

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