Advancing Abuse Deterrence: Is Delaying Opioid Extraction Enough?
As the technology improves, so should the minimum expectations to gain an abuse-deterrent labeling claim, FDA advisory committee members say during review of Pfizer's oxycodone/naltrexone extended-release combination Troxyca.
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First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.