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  • FDA Provides Update on Breakthrough Product Designation Program, Showing Industry Interest

    More than one year has passed since the US Food and Drug Administration (FDA) was first given the authority to give products "breakthrough" designation under the Food and Drug Administration Safety and Innovation Act (FDASIA) , granting companies a range of tools to accelerate the review of a product. But despite not having much in the way of information about the designation until June 2013, sponsors have been nothing but eager to obtain it, according to data released ...
  • In Landmark Move, First Breakthrough Product Obtains FDA Approval

    The US Food and Drug Administration (FDA) has announced its first-ever approval under the breakthrough product designation, a new approval pathway of sorts intended to expedite the process by which highly promising products reach the market. Background Under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, FDA was given the authority to use a new expedited approval program known as breakthrough product designation. As defined by FDA, breakt...
  • Industry Weighs in on Expedited Products Guidance, Calling for Definitional Clarity

    In June 2013, the US Food and Drug Administration (FDA) released a long-awaited and much-anticipated guidance document on its new breakthrough product designation , and in the process of doing so overhauled much of its existing guidance on so-called "expedited programs" as well. Now one of the pharmaceutical industry's most prominent groups is weighing in on the topic, saying that while the guidance is "critical," extensive changes to definitions are warranted. Backgrou...
  • 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...
  • Woodcock Lauds First Submission of 'Breakthrough' Product

    The US Food and Drug Administration (FDA) has already accepted its first product under its new "Breakthrough" therapies designation, and more are soon to be on the way, a high-ranking agency official said recently. In a 3 December 2012 announcement posted on FDA's Voice blog, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), sought to explain the law, calling it an exciting development for an agency that has long searched for effective...
  • Feature ArticlesFeature Articles

    Perspective: Advancing Breakthrough Therapies for Patients

    Advances in science and medicine are leading to exciting possibilities for the treatment of serious or life-threatening conditions, such as cancer. Growing knowledge of disease biology and molecular targets has shifted drug development from a traditional "shotgun" approach to targeted, precision medicines. Understanding the biological basis and natural history of a complex disease, such as cancer, unlocks the potential for new treatment options. In particular, novel-nov...
  • 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 ...