TY - JOUR
KW - abuse-deterrent formulations
KW - Advisory Committees/legislation & jurisprudence
KW - Analgesics, Opioid/adverse effects/chemistry
KW - Drug Approval/legislation & jurisprudence
KW - Drug Compounding
KW - Drug Labeling/legislation & jurisprudence
KW - Humans
KW - Opioid-Related Disorders/diagnosis/epidemiology/prevention & control
KW - Practice Guidelines as Topic
KW - Protective factors
KW - Risk Factors
KW - United States
KW - United States Food and Drug Administration/legislation & jurisprudence
AU - C. J. Miller
AU - R. C. Dart
AU - N. P. Katz
AU - L. R. Webster
A1 - 
AB - It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data submitted by the sponsor are sufficient to support marketing approval and labeling of the product with properties expected to deter abuse by specific routes of abuse (ie, oral, intranasal, intravenous). The FDA has typically followed the approval and labeling recommendations for ADFs reviewed by its Advisory Committees, highlighting the importance of these meetings in the regulatory approval process. This review describes common issues considered by Advisory Committees for ADF opioids as well as insights on how to prepare for these meetings based on recent relevant experience and regulatory decisions.
AD - 3D Communications, Raleigh, North Carolina.; Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado.; Analgesic Solutions, Natick, Massachusetts; Adjunct Associate Professor, Department of Anesthesiology, Tufts University School of Medicine, Boston, Massachusetts.; Vice President of Scientific Affairs, PRA Health Sciences, Salt Lake City, Utah.
BT - Journal of opioid management
C5 - Opioids & Substance Use
CP - 6
CY - United States
IS - 6
JF - Journal of opioid management
M1 - Journal Article
N2 - It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data submitted by the sponsor are sufficient to support marketing approval and labeling of the product with properties expected to deter abuse by specific routes of abuse (ie, oral, intranasal, intravenous). The FDA has typically followed the approval and labeling recommendations for ADFs reviewed by its Advisory Committees, highlighting the importance of these meetings in the regulatory approval process. This review describes common issues considered by Advisory Committees for ADF opioids as well as insights on how to prepare for these meetings based on recent relevant experience and regulatory decisions.
PP - United States
PY - 2017
SN - 1551-7489; 1551-7489
SP - 379
EP - 389
EP - 
T1 - Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids
T2 - Journal of opioid management
TI - Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids
U1 - Opioids & Substance Use
U2 - 29308585
VL - 13
VO - 1551-7489; 1551-7489
Y1 - 2017
Y2 - Nov/Dec
ER -