Literature DB >> 28687816

Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic.

Scott Gottlieb1, Janet Woodcock1.   

Abstract

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Year:  2017        PMID: 28687816     DOI: 10.1001/jama.2017.9205

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


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  6 in total

1.  Regulatory Change Versus Legislation Impacting Health Care Decisions and Delivery.

Authors:  F Randy Vogenberg; Mary Smart
Journal:  P T       Date:  2018-01

Review 2.  Benefit-risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations.

Authors:  Bethea A Kleykamp; Robert H Dworkin; Dennis C Turk; Zubin Bhagwagar; Penney Cowan; Christopher Eccleston; Susan S Ellenberg; Scott R Evans; John T Farrar; Roy L Freeman; Louis P Garrison; Jennifer S Gewandter; Veeraindar Goli; Smriti Iyengar; Alejandro R Jadad; Mark P Jensen; Roderick Junor; Nathaniel P Katz; J Patrick Kesslak; Ernest A Kopecky; Dmitri Lissin; John D Markman; Michael P McDermott; Philip J Mease; Alec B O'Connor; Kushang V Patel; Srinivasa N Raja; Michael C Rowbotham; Cristina Sampaio; Jasvinder A Singh; Ilona Steigerwald; Vibeke Strand; Leslie A Tive; Jeffrey Tobias; Ajay D Wasan; Hilary D Wilson
Journal:  Pain       Date:  2021-09-09       Impact factor: 7.926

3.  Intranasal Pharmacokinetics of Morphine ARER, a Novel Abuse-Deterrent Formulation: Results from a Randomized, Double-Blind, Four-Way Crossover Study in Nondependent, Opioid-Experienced Subjects.

Authors:  Lynn R Webster; Carmela Pantaleon; Matthew Iverson; Michael D Smith; Eric R Kinzler; Stefan Aigner
Journal:  Pain Res Manag       Date:  2018-04-23       Impact factor: 3.037

4.  Empirical Studies Addressing the Opioid Epidemic: An Urgent Call for Research.

Authors:  Gregory L Stuart; Ryan C Shorey; Christopher R France; Jenny Macfie; Kathryn Bell; Kimberly B Fortner; Craig V Towers; Paul Schkolnik; Susan Ramsey
Journal:  Subst Abuse       Date:  2018-08-12

5.  The Xyrem® (Sodium Oxybate) Risk Evaluation and Mitigation Strategy (REMS) Program in the USA: Results From 2016 to 2017.

Authors:  Michael J Strunc; Jed Black; Prasheel Lillaney; Judi Profant; Sherice Mills; Shay Bujanover; Michael J Thorpy
Journal:  Drugs Real World Outcomes       Date:  2021-01-13

6.  Patterns of Immediate-Release and Extended-Release Opioid Analgesic Use in the Management of Chronic Pain, 2003-2014.

Authors:  Catherine S Hwang; Elizabeth M Kang; Yulan Ding; Josephine Ocran-Appiah; Jana K McAninch; Judy A Staffa; Cynthia J Kornegay; Tamra E Meyer
Journal:  JAMA Netw Open       Date:  2018-06-01
  6 in total

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