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Two FDA advisory committees voted 14-3 against approval recommendation for Remoxy ER, voicing concerns over the product's claims of abuse deterrence via various routes. Medscape Medical News
FDA finds no benefit in deterring intranasal abuse; final data not yet submitted to determine IV abuse deterrence.
The agency is assessing whether to use different language to describe addiction and abuse deterrence.
Agency reviewers see lower potential for intranasal abuse with Pain Therapeutics' extended-release opioid compared to immediate-release oxycodone, but an increased...
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidan...
Helsinn v. Teva challenges whether inventor's sale of an invention to a third party that must in turn keep the...
ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages...
Getting to identify a drug abuse case and determining whether it is appropriate to join a rehab center is not as easy. Mostly, physical signs... Read More →
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Timely access to trauma center(TC) care is critical to achieve "Zero Preventable Deaths After Injury." However, the impact of timely access to TC care on pre-hospital deaths in each US state remains u...
While several elder abuse screens exist, few measure risk and none target long-term support services. The aims were to examine the psychometric properties of the Weinberg Center Risk and Abuse Prevent...
To understand the reasons attributed by women to the abuse of psychoactive substances.
One in three children will experience sexual violence before they are 18 years old. The recognition and evaluation of alleged child sexual abuse is complex. Presently there are no validated, self-cont...
In 2012, Access Community Health Network, a Federally Qualified Health Center (FQHC) network with 36 health centers serving the greater Chicago area, embarked on a 3-year initiative to improve patient...
A feasibility trial to determine whether six months access to the New Zealand 'Step Away' app can reduce the frequency of alcohol abuse and increase engagement with substance abuse-related...
Although abuse by an intimate partner is very common and has serious negative effects on women's health, few studies have been done to test ways to increase safety for women in abusive rel...
The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.
The purpose of this study is: (1) to assess the effect of oxycodone HCl on niacin-induced dysphoric effects when oxycodone HCl is administered in combination with niacin in subjects with a...
dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least two weeks.
Tris Pharma is a product-focused, specialty pharmaceutical company engaged in the research and development of innovative drug delivery technologies. Through its OralXR+ platform, Tris has pioneered th...
The Prescription Drug Research Center is located at the Mason Enterprise Center, a part of George Mason University, in Fairfax, Virginia. As a member of the Mason Enterprise Center, PDRC enjoys access...
With almost 70 years of experience, Didi Hirsch provides mental health and substance abuse services at ten sites in Los Angeles and Orange County. A member of the National Suicide...
Gatekeeper Innovation saves lives endangered by prescription drug abuse. The company makes affordable products that reduce prescription abuse potential and, in doing so, ch...
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