TSXV:IPCI.H - Post by User
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Normandt1965on Apr 02, 2021 10:08am
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Opioid (deterrent)
Opioid (deterrent)2021 February: On February 1, the FDA provided an update on the pilot program with the National Telecommunications and Information Administration (NTIA) and three domain name registries to help reduce the availability of unapproved opioids illegally offered for sale online. February: On February 16, the FDA issued a warning letter to AcelRx Pharmaceuticals, Inc. for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic. March: On March 1, the FDA approved Hydrocodone bitartrate (reference listed drug: Hysingla ER), the first FDA-approved generic opioid with an abuse-deterrent formulation (ADF)meaning the product has properties that are expected to reduce, though not totally prevent, abuse of the drug when chewed and then taken orally or crushed and snorted or injected. March: On March 24, the FDA issued a white paper, Introduction to FDAs Opioid Systems Model, which introduces FDAs opioid systems modeling effort, discusses potential uses of the model, provides an overview of the models scope and structure, highlights preliminary areas for potential policy analysis and outlines on-going work.