Literature DB >> 25587952

Practical, legal, and ethical issues in expanded access to investigational drugs.

Jonathan J Darrow, Ameet Sarpatwari, Jerry Avorn, Aaron S Kesselheim.   

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Year:  2015        PMID： 25587952     DOI： 10.1056/NEJMhle1409465

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  31 in total

1.  Right-to-try laws and individual patient "compassionate use" of experimental oncology medications: A call for improved provider-patient communication.

Authors:  Michael Hoerger
Journal:  Death Stud       Date:  2015-08-27

Review 2.  Ethics codes and use of new and innovative drugs.

Authors:  Jan Borysowski; Hans-Jörg Ehni; Andrzej Górski
Journal:  Br J Clin Pharmacol       Date:  2019-01-04       Impact factor: 4.335

3.  Medical Negligence Determinations, the "Right to Try," and Expanded Access to Innovative Treatments.

Authors:  Denise Meyerson
Journal:  J Bioeth Inq       Date:  2017-06-20       Impact factor: 1.352

4.  A Response to Meyerson's Defence of the American Right to Try : Experimenting with hope.

Authors:  Oliver Kim
Journal:  J Bioeth Inq       Date:  2019-08-23       Impact factor: 1.352

Review 5.  An overview of Compassionate Use Programs in the European Union member states.

Authors:  Gayathri Balasubramanian; Suman Morampudi; Pankdeep Chhabra; Arun Gowda; Behsad Zomorodi
Journal:  Intractable Rare Dis Res       Date:  2016-11

6.  Overview of FDA's Expanded Access Program for Investigational Drugs.

Authors:  Jonathan P Jarow; Peter Lurie; Sarah Crowley Ikenberry; Steven Lemery
Journal:  Ther Innov Regul Sci       Date:  2017-03-01       Impact factor: 1.778

7.  Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations.

Authors:  Tobias B Polak; David G J Cucchi; Joost van Rosmalen; Carin A Uyl-de Groot; Jonathan J Darrow
Journal:  Front Pharmacol       Date:  2022-05-23       Impact factor: 5.988

8.  Gene therapy companies have an ethical obligation to develop expanded access policies.

Authors:  Lisa Kearns; Carolyn Riley Chapman; Kenneth I Moch; Arthur L Caplan; Tom Watson; Andrew McFadyen; Pat Furlong; Alison Bateman-House
Journal:  Mol Ther       Date:  2021-03-13       Impact factor: 11.454

9.  Going "social" to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access.

Authors:  Tim K Mackey; Virginia J Schoenfeld
Journal:  BMC Med       Date:  2016-02-02       Impact factor: 8.775

10.  An analysis of common ethical justifications for compassionate use programs for experimental drugs.

Authors:  Kasper Raus
Journal:  BMC Med Ethics       Date:  2016-10-18       Impact factor: 2.652
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