FDA to reevaluate Menaflex approval process

FDA released a report on Thursday recommending a reevaluation of the approval of a 510(k) application from ReGen Biologics Inc. (OTCBB:RGBO) for Menaflex collagen meniscus implant for reinforcement and repair of soft tissue injuries of the medial meniscus. The report states that during the Menaflex review, the agency failed to respond appropriately to external pressure on decision makers, excluded individuals from parts of the scientific debate, and excessively relied on advisory panels in reaching a final decision to clear the device. FDA said on a conference call that the product, which was approved in December, will remain on the market during the reevaluation. ReGen was unchanged on Thursday at $1.98. ...