Devices

Allergan Missing Breast Implant Study Requirements

FDA says that Allergan is not meeting the post-approval study requirements associated with its Natrelle silicone-filled breast implants (round responsive implants) and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. A 5/14 Warning Letter says the studies were required to provide information on the long-term device performance and to evaluate device performance under general conditions of use.

The agency says the company has failed to comply with three of the five requirements for the round responsive implant study and two of the seven requirements for the 410 style implant study.

The letter warns the company that failing to conduct required studies could be grounds for withdrawal of approval of a PMA. Allergan was told to take prompt action to correct the violations and to respond with a plan addressing the issues in the letter or with documentation showing that it has complied with the post-approval requirements. FDA also wants a list of specific steps the company has taken to correct the violations and prevent their recurrence, with supporting documentation and a schedule 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