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Purdue Pharma L.P.

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Latest From Purdue Pharma L.P.

Virtual Advisory Committees: US FDA Clears A Big Test With OxyContin Meeting

Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.

Advisory Committees Coronavirus COVID-19

A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

FDA Coronavirus COVID-19

OxyContin Abuse Deterrent Formulation Voted Beneficial By FDA Panel, But Questions Remain

Label change is one option after US advisory committee review of Purdue’s postmarketing studies concludes reformulated OxyContin ‘meaningfully reduced abuse’ by non-oral routes, but finds there is not evidence to show such reduction via all routes or that ADF reduced risk of opioid overdose. 

Advisory Committees Post Market Regulation & Studies

OxyContin Reformulation Reduced Abuse Via Non-Oral Routes But Not Overall Abuse, US FDA Finds

FDA says it is unclear whether Purdue’s OxyContin abuse deterrent reformulation reduced opioid overdoses or had a net public health benefit. Briefing document for upcoming advisory committee meeting asks panel to discuss Purdue’s four postmarket studies but does not include voting question on possible change in labeling claims.

Advisory Committees Risk Management
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