Concepedia

Regulatory Strategy

Regulatory Strategy is a deliberate, forward-looking plan of action that integrates scientific, clinical, manufacturing, and nonmarket considerations to shape and navigate the regulatory environment governing the development, approval, and lifecycle management of biomedical products, thereby aligning organizational objectives with evolving statutory, administrative, and policy requirements.

517

Publications

26.8K

Citations

1.3K

Authors

656

Institutions

Publications per year

2017–2026

164

Parents

Children

Publications

517

Regulatory Focus and Strategic Inclinations: Promotion and Prevention in Decision-Making

Ellen Crowe, E. Tory Higgins · Organizational Behavior and Human Decision Processes · 1997 · 2K citations

, , +11

INDUSTRY SELF-REGULATION WITHOUT SANCTIONS: THE CHEMICAL INDUSTRY'S RESPONSIBLE CARE PROGRAM.

A. A. King, Michael Lenox · Academy of Management Journal · 2000 · 1.6K citations

, , +13

Going by the Book, the Problem of Regulatory Unreasonableness

M. Gordon Wolman, Eugene Bardach, Robert A. Kagan · Journal of Policy Analysis and Management · 1983 · 849 citations · Full text

, , +11

Contested Boundaries in Policy-Relevant Science

Sheila Jasanoff · Social Studies of Science · 1987 · 803 citations

, , +17

The Planned Introduction of Genetically Engineered Organisms: Ecological Considerations and Recommendations

James M. Tiedje, Robert K. Colwell, Y.L. Grossman et al. · Ecology · 1989 · 628 citations

, , +17

1–5 of 517

Authors

1.3K

  1. AF
    Alex Faulkner

    University of Sussex, United Kingdom

    6 publications · 142 citations

    6

    h-index

  2. DE
    David E. M. Sappington

    University of Florida, United States

    4 publications · 308 citations

    4

    h-index

  3. MH
    Margaret Hamburg

    United States Food and Drug Administration, United States

    4 publications · 190 citations

    4

    h-index

  4. GE
    Gary E. Marchant

    Arizona State University, United States

    4 publications · 170 citations

    4

    h-index

  5. SS
    Sam Salek

    University of Hertfordshire, United Kingdom

    4 publications · 64 citations

    4

    h-index

1–5 of 1.3K

Institutions

656

  1. United States Food and Drug Administration

    Silver Spring, United States

    14 h-index

    45 publications

    1.6K citations

  2. University of Sussex

    Brighton, United Kingdom

    10 h-index

    15 publications

    405 citations

  3. Center for Drug Evaluation and Research

    Silver Spring, United States

    9 h-index

    19 publications

    1K citations

  4. University of Oxford

    Oxford, United Kingdom

    8 h-index

    9 publications

    831 citations

  5. Utrecht University

    Utrecht, The Netherlands

    7 h-index

    17 publications

    479 citations

  6. University of Michigan

    Ann Arbor, United States

    7 h-index

    8 publications

    408 citations

  7. KU Leuven

    Leuven, Belgium

    6 h-index

    12 publications

    406 citations

  8. Arizona State University

    Tempe, United States

    6 h-index

    9 publications

    505 citations

1–8 of 656

Venues

  1. SSRN Electronic Journal

    Repository · 23 publications · 773 citations

    16

    h-index

  2. Frontiers in Medicine

    12 publications · 347 citations

    11

    h-index

  3. Nature Biotechnology

    10 publications · 358 citations

    10

    h-index

  4. PubMed

    Repository · 10 publications · 311 citations

    10

    h-index

  5. Science

    6 publications · 243 citations

    6

    h-index

1–5