• Regulatory NewsRegulatory News

    Edwards Recalls Part of Transcatheter Heart System After One Death

    Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...
  • Regulatory NewsRegulatory News

    PMA Denials: Why so Few?

    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...
  • Regulatory NewsRegulatory News

    FDA Used Real-World Evidence in Heart Valve Approval

    The US Food and Drug Administration (FDA) says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) to valve-in-valve procedures. In a blog post Wednesday, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren and Bram Zuckerman, director of CDRH's Division of Cardiovascular Devices touted the agency's turnaround from 42nd in the world to approve a TAVR devic...
  • Regulatory NewsRegulatory News

    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...
  • FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve

    Review staff from the US Food and Drug Administration (FDA) said Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) met trial endpoints for safety and effectiveness for the treatment of high-risk severe aortic stenosis, but expressed concern about trial biases, long-term risks to patients and the statistical validity of some of Edwards' findings. Edwards' device is set to go before a meeting of the Circulatory Systems Advisory Committee on 13 June, where Edward...
  • Novartis Gets Mixed News on MS, HCV Drugs From EMA, FDA

    Swiss pharmaceuticals manufacturer Novartis AG received mixed news from European and American regulators on 18 April, with the European Medicines Agency (EMA) approving its multiple sclerosis drug GIlenya with some additional warnings, and the US Food and Drug Administration (FDA) demanding a phase III trial for its hepatitis C drug alisporivir be halted after safety concerns were raised. EMA's decision on GIlenya came after some concerns about the drug's safety were r...