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  • Regulatory NewsRegulatory News

    US Government Wants to Know More About the Biotech Ecosystem

    The White House’s Office of Science Technology and Policy (OSTP) on Tuesday sought input from any and all biotech stakeholders on the innovation, products, technology and data derived from biologically-related processes and science that drive economic growth, promote health and increase public benefit. Referred to as the “Bioeconomy,” OSTP said it’s seeking comments before 23 October from the public, including those with capital investments, those performing research or...
  • FDA's Chief Scientist Reveals Planned Animal Rule Revisions, Regulatory Science Initiatives

    US Food and Drug Administration's (FDA) Chief Scientist Jesse Goodman gave a presentation to FDA's Science Board on 2 May, laying out a number of upcoming FDA activities and priorities including the agency's planned revision of its Animal Rule draft guidance and a number of new regulatory science initiatives. Goodman noted FDA has selected three projects from a pool of 35 applicants for its regulatory science Challenge Grant program. The three projects aim to create biom...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...