Literature DB >> 25813980

Dispensing medical countermeasures: emergency use authorities and liability protections.

Charles G Kels.   

Abstract

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) enhances emergency use authorities with respect to both approved and unapproved medical countermeasures (MCMs). PAHPRA authorities can also be critical to preserving tort liability protections for public health stakeholders, since these protections are often contingent upon appropriate authorizations for the MCMs utilized. This article details the evolution of emergency use authorities and liability protections, analyzes how these separate legal doctrines can intersect in practice, and discusses implications for facilitating preparedness and response activities and for protecting associated personnel.

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Year:  2015        PMID: 25813980      PMCID: PMC4394170          DOI: 10.1089/hs.2014.0059

Source DB:  PubMed          Journal:  Health Secur        ISSN: 2326-5094


  7 in total

1.  Notes and comments "High and dry?" The Public Readiness and Emergency Preparedness Act and liability protection for pharmaceutical manufacturers.

Authors:  B Kurt Copper
Journal:  J Health Law       Date:  2007

Review 2.  Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies, United States.

Authors:  Stuart L Nightingale; Joanna M Prasher; Stewart Simonson
Journal:  Emerg Infect Dis       Date:  2007-07       Impact factor: 6.883

3.  The PREP Act: liability protection for medical countermeasure development, distribution, and administration.

Authors:  Peggy Binzer
Journal:  Biosecur Bioterror       Date:  2008-12

4.  Emergency Use Authority and 2009 H1N1 influenza.

Authors:  Susan E Sherman; Joseph Foster; Sonal Vaid
Journal:  Biosecur Bioterror       Date:  2009-09

5.  Ten common questions (and their answers) about off-label drug use.

Authors:  Christopher M Wittich; Christopher M Burkle; William L Lanier
Journal:  Mayo Clin Proc       Date:  2012-08-06       Impact factor: 7.616

6.  Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Authors:  Brooke Courtney; Susan Sherman; Matthew Penn
Journal:  J Law Med Ethics       Date:  2013-03       Impact factor: 1.718

7.  Heterogeneous lamella structure unites ultrafine-grain strength with coarse-grain ductility.

Authors:  Xiaolei Wu; Muxin Yang; Fuping Yuan; Guilin Wu; Yujie Wei; Xiaoxu Huang; Yuntian Zhu
Journal:  Proc Natl Acad Sci U S A       Date:  2015-11-09       Impact factor: 11.205

  7 in total
  1 in total

Review 1.  Medical countermeasures for unwanted CBRN exposures: part II radiological and nuclear threats with review of recent countermeasure patents.

Authors:  Vijay K Singh; Patricia L P Romaine; Victoria L Newman; Thomas M Seed
Journal:  Expert Opin Ther Pat       Date:  2016-09-09       Impact factor: 6.674

  1 in total

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