• FDA Releases Long-Awaited Guidance on Breakthrough Product Designation

    The US Food and Drug Administration (FDA) has released a new guidance document pertaining to the use of so-called "expedited programs" for serious conditions by the pharmaceutical and biotechnology industries, including a new designation known as breakthrough product designation. Background At FDA, fast track development is meant to focus agency resources on an application for a promising drug or biological product intended for a serious or life-threatening condition fo...
  • Pfizer Claims Fourth Breakthrough Product Designation, But Joins Others in Citing Unclear Benefit

    Pharmaceutical manufacturing giant Pfizer has announced that its breast cancer candidate palbociclib has received a new and coveted breakthrough product designation from the US Food and Drug Administration (FDA), the third company and fourth product to announce their receipt of the designation to date. Background Though many companies are seeking breakthrough product designation-40 requests in all through 31 March 2013, by FDA's count --It's not entirely clear what the...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster

    • 23 April 2012
    Former US Food and Drug Administration (FDA) Commissioner Mark McClellan, now a member of the think tank The Brookings Institute, penned an opinion piece in The Hill in which he argues FDA must take advantage of a "paradigm shift" in our understanding of specific pathways of disease to get treatments to patients faster. "Our progress in understanding the specific pathways of disease has identified hundreds of new targets for potentially life-saving drugs that hold ...