• Regulatory NewsRegulatory News

    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
  • Regulatory NewsRegulatory News

    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...
  • New Report Calls for Overhaul of Regulatory Processes with Goal of Doubling Drug Approvals by 2027

    A new report released by the President's Council of Advisors on Science and Technology (PCAST) has called for the US Food and Drug Administration (FDA) to approximately double the number of pharmaceutical products it approves each year by the end of 2027. The report, Propelling Innovation in Drug Discovery, Development and Evaluation , comes on the heels of two reports released earlier in 2012 which called for, respectively, a more refined regulatory approach for n...
  • Report Highlights Potential Impact of Spectrum Changes on Medical Device Innovation

    • 23 July 2012
    A new report out by the President's Council of Advisors on Science and Technology (PCAST) makes the case that blocks of carefully managed wireless spectrum may be of increasing importance to future medical device innovation. The report, Realizing the Full Potential of Government-Held Spectrum to Spur Economic Growth , comes just two months after the Federal Communication Commission (FCC) announced its own first-in-the-world plan to dedicate a band of wireless spectrum...
  • US Agency Releases Assessment Report on Nanotechnology, Calls for Refined Regulatory Approach

    • 30 April 2012
    The President's Council of Advisors on Science and Technology (PCAST) has released a report assessing the US's progress in implementing a broad-based program to promote the research and development of nanotechnologies, including regulatory strategies aimed at generating new medicines and technologies. One of the PCAST report's highest concerns was for workplace safety and implementing and enforcing adequate regulations to ensure manufacturing facilities are safe for work...