Concepedia

Regulatory Exclusivity

Regulatory Exclusivity is a statutory, time-limited form of market protection in pharmaceutical regulation whereby a drug regulatory authority, upon granting marketing authorization, restricts its own ability to file or approve competing applications that rely on the originator’s safety and efficacy data for a defined period, independently of and in addition to patent rights.

160

Publications

5.7K

Citations

406

Authors

241

Institutions

Publications per year

2017–2026

40

Parents

Children

Publications

160

Is EMU more justifiable ex post than ex ante?

Jeffrey A. Frankel, Andrew K. Rose · European Economic Review · 1997 · 479 citations

, , +4

Regulatory objectivity and the generation and management of evidence in medicine

Alberto Cambrosio, Peter Keating, Thomas Schlich et al. · Social Science & Medicine · 2006 · 252 citations

, , +11

Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program

Jennifer S. Li, Eric L. Eisenstein, Henry G. Grabowski et al. · JAMA · 2007 · 170 citations · Full text

, , +17

Incentives for orphan drug research and development in the United States

Enrique Seoane‐Vazquez, Rosa Rodríguez-Monguió, Sheryl L. Szeinbach et al. · Orphanet Journal of Rare Diseases · 2008 · 138 citations · Full text

, , +17

Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Biotechnology Law Report · 2011 · 136 citations

, , +13

1–5 of 160

Authors

406

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    9 publications · 351 citations

    9

    h-index

  2. HG
    Henry G. Grabowski

    Duke University, United States

    5 publications · 409 citations

    5

    h-index

  3. RF
    Reed F. Beall

    University of Calgary, Canada

    4 publications · 124 citations

    4

    h-index

  4. AS
    Ameet Sarpatwari

    Brigham and Women's Hospital, United States

    3 publications · 83 citations

    3

    h-index

  5. WB
    William B. Feldman

    Brigham and Women's Hospital, United States

    2 publications · 51 citations

    2

    h-index

1–5 of 406

Institutions

241

  1. Harvard University

    Cambridge, United States

    10 h-index

    19 publications

    488 citations

  2. Brigham and Women's Hospital

    Boston, United States

    9 h-index

    26 publications

    758 citations

  3. Duke University

    Durham, United States

    6 h-index

    7 publications

    388 citations

  4. Mario Negri Institute for Pharmacological Research

    Milan, Italy

    4 h-index

    6 publications

    157 citations

  5. Istituti di Ricovero e Cura a Carattere Scientifico

    Rome, Italy

    3 h-index

    4 publications

    121 citations

  6. University of Michigan

    Ann Arbor, United States

    3 h-index

    3 publications

    64 citations

  7. London School of Economics and Political Science

    London, United Kingdom

    3 h-index

    4 publications

    101 citations

  8. University of Sussex

    Brighton, United Kingdom

    3 h-index

    3 publications

    106 citations

1–8 of 241

Venues

  1. SSRN Electronic Journal

    Repository · 11 publications · 280 citations

    10

    h-index

  2. PubMed

    Repository · 9 publications · 178 citations

    9

    h-index

  3. Health Affairs

    7 publications · 367 citations

    7

    h-index

  4. New England Journal of Medicine

    NEJM · 5 publications · 132 citations

    5

    h-index

  5. JAMA

    5 publications · 228 citations

    5

    h-index

1–5