• New guidance from FDA on overseas medical device clinical trials

    The FDA announces a new draft of their guidance on standards for accepting data from overseas studies in medical device clinical trials. With the increase in overseas trials, the FDA is attempting to clarify its existing policies on how overseas trials can be designed. The draft guidance relates to the FDA’s practice of accepting sound data from trials in other countries. In a footnote, the FDA states, “This guidance is also applicable to those medical devices reviewed as biological products under the PHS Act through submission of Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs).”The FDA announces a new draft of their guidance on standards for accepting data from overseas studies in medical device clinical trials.
  • Update from REITWise 2015

    The National Association of Real Estate Investment Trusts (NAREIT) held their annual REITWise conference in Phoenix, Ariz. The latest accounting, tax, and economic issues impacting real estate investment trusts (REITs) were addressed over the course of the conference. Highlights from some of the committee meetings and sessions are summarized.