Devices

AdvaMed Prioritizes CDRH Proposed Guidances

AdvaMed has submitted its suggested priorities for CDRH’s FY 2016 proposed guidance development. The trade group also submitted recommendations for guidance documents it believes should be part of the Center’s 2016 plans, but are not, along with recommendations on guidances to be updated or withdrawn.

For proposed guidances listed in the Center’s “A” and “B” lists, AdvaMed assigned a high, medium, or low priority as determined by its member companies. It said that high priority guidances are those that have the potential to broadly affect industry, have high impact on routine administrative and/or review procedures at FDA, address an area where guidance may currently be lacking, or is required under the MDUFA 3 commitment letter or FDASIA legislation.

Medium priority documents also may broadly affect industry, but may not be absolutely critical to FDA’s routine administrative and/or review procedures. Finally, low priority documents as determined by AdvaMed have a lesser impact on agency procedures or address a subject that is highly specialized or narrowly focused.

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