• Regulatory NewsRegulatory News

    Updated: GDUFA II Performance Goals: 8-Month Priority Reviews, More Timely Correspondence

    The US Food and Drug Administration (FDA) will speed the review of abbreviated new drug applications (ANDAs) and work with generic drugmakers on a closer and more timely basis, according to the draft performance goals and program enhancements for the Generic Drug User Fee Act (GDUFA) reauthorization for FYs 2018-2022, known as GDUFA II. The GDUFA II performance goals letter, released last Friday, follows more than a year of negotiations between FDA and the...
  • Regulatory NewsRegulatory News

    The Next PDUFA: New Performance and Procedural Goals

    Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022. The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projec...
  • Brazil: Anvisa Restructuring to Meet Social, Economic Development Goals

    The Chief Executive of Brazilian regulatory authority Anvisa says the ongoing restructuring process at the agency is focused on the economic and social development of the country. The agency reforms are in recognition of a new Brazilian regulatory approach aiming to have a broader effect on society, said Dirceu Barbano, chief executive of Anvisa, in remarks before the Brazilian Congress on 8 May. "Having one eye on the country's economic development is one way to combat...
  • GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

    The US Government Accountability Office (GAO) released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device reviews, but that overall medical device review time was trending upward. The discrepancy comes down to a difference in how FDA's performance is evaluated relative to the total time it takes to review a medical device under the 510(k) evaluation pathway. Under so-called "...
  • CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

    The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012.  The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives. CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant infor...