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Literature DB >> 20140107

Off-label drug information: regulation, distribution, evaluation, and related controversies.

C Lee Ventola.

Abstract

Year: 2009 PMID： 20140107 PMCID： PMC2799128

Source DB: PubMed Journal: P T ISSN： 1052-1372

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9 in total

Review 1. The role of marketing in pharmaceutical research and development.

Authors: John E Calfee
Journal: Pharmacoeconomics Date: 2002 Impact factor: 4.981

2. Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.

Authors: James O'Reilly; Amy Dalal
Journal: Ann Health Law Date: 2003

3. Experts weigh in on promotion, prescription of off-label drugs.

Authors: Tracy Hampton
Journal: JAMA Date: 2007-02-21 Impact factor: 56.272

4. Shifting terrain in the regulation of off-label promotion of pharmaceuticals.

Authors: Michelle M Mello; David M Studdert; Troyen A Brennan
Journal: N Engl J Med Date: 2009-04-09 Impact factor: 91.245

5. New FDA guidance on off-label promotion falls short for everyone: obama administration is likely to revisit it.

Authors: Stephen Barlas
Journal: P T Date: 2009-03

6. FDA guidance on off-label promotion and the state of the literature from sponsors.

Authors: Bruce M Psaty; Wayne Ray
Journal: JAMA Date: 2008-04-23 Impact factor: 56.272

7. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system.

Authors: Linda S Tyler; Sabrina W Cole; J Russell May; Mirta Millares; Michael A Valentino; Lee C Vermeulen; Andrew L Wilson
Journal: Am J Health Syst Pharm Date: 2008-07-01 Impact factor: 2.637

8. Informed consent and shared decision-making: a requirement to disclose to patients off-label prescriptions.

Authors: Michael Wilkes; Margaret Johns
Journal: PLoS Med Date: 2008-11-11 Impact factor: 11.069

9. Off-label promotion, on-target sales.

Authors: Adriane Fugh-Berman; Douglas Melnick
Journal: PLoS Med Date: 2008-10-28 Impact factor: 11.069

9 in total

12 in total

1. Psychotropic drug treatments for people with autism and other developmental disorders: a primer for practicing behavior analysts.

Authors: Marc Weeden; Kristal Ehrhardt; Alan Poling
Journal: Behav Anal Pract Date: 2010

2. Short-term effects of intravitreal ranibizumab and bevacizumab administration on 24-h ambulatory blood pressure monitoring recordings in normotensive patients with age-related macular degeneration.

Authors: A Sengul; R Rasier; C Ciftci; O Artunay; A Kockar; H Bahcecioglu; E Yuzbasioglu
Journal: Eye (Lond) Date: 2017-01-06 Impact factor: 3.775

10. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.

Authors: Andreas Vilhelmsson; Courtney Davis; Shai Mulinari
Journal: PLoS Med Date: 2016-01-26 Impact factor: 11.069

Off-label drug information: regulation, distribution, evaluation, and related controversies.

Review 1. The role of marketing in pharmaceutical research and development.

2. Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.

3. Experts weigh in on promotion, prescription of off-label drugs.

4. Shifting terrain in the regulation of off-label promotion of pharmaceuticals.

5. New FDA guidance on off-label promotion falls short for everyone: obama administration is likely to revisit it.

6. FDA guidance on off-label promotion and the state of the literature from sponsors.

7. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system.

8. Informed consent and shared decision-making: a requirement to disclose to patients off-label prescriptions.

9. Off-label promotion, on-target sales.

1. Psychotropic drug treatments for people with autism and other developmental disorders: a primer for practicing behavior analysts.

2. Short-term effects of intravitreal ranibizumab and bevacizumab administration on 24-h ambulatory blood pressure monitoring recordings in normotensive patients with age-related macular degeneration.

3. Off-label prescriptions for adult neurological patients: a pilot survey in China.

Review 4. The evidence-based choice for antipsychotics in children and adolescents should be guaranteed.

5. The Prescription Drug User Fee Act: Much More Than User Fees.

6. Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities.

7. The effects of the natural enzyme, Pectinex Ultra SP-L, on human cell cultures and bacterial biofilms in vitro.

8. Strategy to address innovative off-label medication use in China: grading management.

9. Drug utilisation and off-label use of medications in anaesthesia in surgical wards of a teaching hospital.

10. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.