FDA Exempts Naloxone From DSCSA Requirements To Boost Access

FDA on Thursday (Sept. 22) announced it is exempting approved naloxone products, specifically those that are distributed to harm reduction programs, from certain drug tracking, tracing and distribution requirements during the opioid public health emergency in a bid to boost access to naloxone. The Biden administration has said it wants to increase access to and affordability of the overdose reversal drug as part of its broader strategy to address the opioid overdose epidemic, but the administration’s plan is focused more...
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Ohio State University Will Lead Review Of FDA’s Opioid Epidemic Response

FDA has tapped Ohio State University to evaluate the agency’s response to the opioid crisis, and recommend actions the agency can take based on existing and potentially new authorities, FDA chief Robert Califf announced earlier this week, coming three weeks after Califf unveiled the agency’s overdose prevention framework . The review team at Ohio State is familiar with opioid prescribing issues and has knowledge of the National Academies of Sciences Engineering and Medicine report from 2017 that provided recommendations for...
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McConnell Tries Blocking FDA User Fee Policy Riders Agreed To By Burr, Murray

Sens. Patty Murray (D-WA) and Richard Burr (R-NC) announced they have a deal for a “practically clean” reauthorization of FDA user fee programs that would be attached to a temporary government funding bill, but Senate Minority Leader Mitch McConnell (R-KY) wants to eliminate even the few policy riders the two negotiated, according to a McConnell spokesperson. The issue should be resolved soon, a drug lobbyist said. It’s not clear which policy riders are part of the deal between Murray, who...
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McConnell Tries Blocking FDA User Fee Policy Riders Agreed To By Burr, Murray

Sens. Patty Murray (D-WA) and Richard Burr (R-NC) announced they have a deal for a “practically clean” reauthorization of FDA user fee programs that would be attached to a temporary government funding bill, but Senate Minority Leader Mitch McConnell (R-KY) wants to eliminate even the few policy riders the two negotiated, according to a McConnell spokesperson. The issue should be resolved soon, a drug lobbyist said. It’s not clear which policy riders are part of the deal between Murray, who...
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