Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

被引:7
|
作者
Honig, Peter [1 ]
Zhang, Lei [1 ]
机构
[1] US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Off Res & Stand, Silver Spring, MD USA
关键词
DRUG DEVELOPMENT;
D O I
10.1002/cpt.1367
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Regulatory science is defined as science and research intended to inform decision making in a regulatory framework. This issue of Clinical Pharmacology & Therapeutics and the papers herein deal with the expansive topic of regulatory science and its role in fostering innovation and accelerating access to medicines. Regulatory health authorities, industry, and multiple stakeholders have a shared objective in advancing regulatory science to keep up with the ever-increasing pace of biomedical science.
引用
收藏
页码:778 / 781
页数:4
相关论文
共 50 条
  • [42] The role of science parks in the process of innovation
    Parry, M
    [J]. SCIENCE AND INNOVATION AS STRATEGIC TOOLS FOR INDUSTRIAL AND ECONOMIC GROWTH, 1996, 4 : 85 - 95
  • [43] Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective
    Heikkinen, Inkatuuli
    Eskola, Sini
    Acha, Virginia
    Morrison, Alan
    Walker, Chris
    Weill, Catherine
    Bril, Antoine
    Wegner, Max
    Metcalfe, Thomas
    Chibout, Salah-Dine
    Chlebus, Magda
    [J]. DRUG DISCOVERY TODAY, 2023, 28 (05)
  • [44] All Element Innovation Facilitating High Involvement Innovation
    Shui Changqing
    Xu Qingrui
    [J]. 2007 INTERNATIONAL CONFERENCE ON WIRELESS COMMUNICATIONS, NETWORKING AND MOBILE COMPUTING, VOLS 1-15, 2007, : 5935 - 5938
  • [45] The Role of Precompetitive Consortia, Data Sharing, and Regulatory Science in Catalyzing Innovation for Neurodegenerative Diseases
    Stephenson, D.
    [J]. CELL TRANSPLANTATION, 2017, 26 (04) : 726 - 726
  • [46] The Role of Precompetitive Consortia, Data Sharing, and Regulatory Science in Catalyzing Innovation for Neurodegenerative Diseases
    Stephenson, D.
    [J]. CELL TRANSPLANTATION, 2017, 26 : 726 - 726
  • [47] INNOVATION IN REGULATORY SCIENCE: EVOLUTION OF A NEW SCIENTIFIC DISCIPLINE
    Moghissi, A. Alan
    Straja, Sorin R.
    Love, Betty R.
    Bride, Dennis K.
    Stough, Roger R.
    [J]. TECHNOLOGY AND INNOVATION, 2014, 16 (02) : 155 - 165
  • [48] Biopesticide registration: The state-of-the-science and regulatory innovation
    Bourgoin, Marjorie
    Fife, Jane
    Weidenauer, Matthias
    [J]. ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2014, 248
  • [49] The role of the regulatory environment in fostering innovation and growth
    Dutz, M
    [J]. PRIVATISATION, COMPETITION AND REGULATION, 2000, : 161 - 173
  • [50] Interaction analysis between innovation and regulation: The concept of Regulatory Science as a Process (RaaP) and its applications
    Kano, Shingo
    [J]. PICMET 2016 - Portland International Conference on Management of Engineering and Technology: Technology Management For Social Innovation, Proceedings, 2017, : 1278 - 1285