• New FDA Device Guidance Aims to Protect Against Transmissible Spongiform Encephalopathies

    The public often thinks of medical devices as complicated constructs of metal, plastics and electronics, but the fact is that many medical devices are made from animal-derived materials as well. Some constitute large parts of the device, such as a bone substitute or bovine heart valve; others are smaller portions, such as a heparin coating on a device. But as a new guidance from the US Food and Drug Administration (FDA) notes, whatever portion of the device is made from...
  • EMA Draft Guidance Adds Testing Requirements for Manufacturers of Bovine Serum

    The European medicines Agency (EMA) has released a new draft guideline for manufacturers who use bovine serum when producing biologics for human consumption, adding additional testing requirements to screen for bovine viral diarrhea virus (BVDV). The 1 October draft guideline, Use of bovine serum in the manufacture of human biological medicinal products , specifically revises two sections of a 2003 guideline on the same topic: Sections 7.3.3 and 7.3.4, both of which per...