Tag Archives: FDA

Mediledger completes FDA blockchain pilot with 7 of top 10 pharma firms – Ledger Insights

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According to the article:

“Blockchain startup Mediledger has published the results of its FDA blockchain pilot for the pharmaceutical supply chain. Numerous separate groups applied to the FDA and ran pilots for the Drug Supply Chain Security Act (DSCSA) 2023 milestone for package-level tracing, with this being one of the largest groups. Mediledger’s participants included all three major U.S. wholesalers, seven out of ten of the world’s largest pharmaceutical companies, massive dispensers Walgreens and Walmart, as well as logistics firms such as FedEx.”

Read the source article:  Mediledger completes FDA blockchain pilot with 7 of top 10 pharma firms – Ledger Insights

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Here comes drug importation – Pharmaceutical Commerce

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According to the article:

“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”

Read the source article:  Here comes drug importation – Pharmaceutical Commerce

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At Least 2.5 Million Home Health Patients Using Medical Equipment Vulnerable to Natural Disasters – HomeHealthCareNews

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““Health care trends suggest that 2.5 million number is just going to continue to grow as more people opt to age in place,” Marriele Mango, lead author of the study and resilient power fellowship program associate for Clean Energy Group, told HHCN. “In the end, energy security just isn’t there for them in the way that it is in a nursing home, assisted living home or a hospital.”

In the event of a natural disaster, lack of energy security can be fatal.”

Read the full source article:  At Least 2.5 Million Home Health Patients Using Medical Equipment Vulnerable to Natural Disasters – HomeHealthCareNews.com

You might also be interested in:   FDA – Hurricane Checklist – Medical Devices

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The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt

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The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt

“Pharmacies are being asked [to] provide transaction history, transaction information, and transaction statement, and to maintain such records for not less than six years after the transaction.”

“Pharmacies are expected to ensure that wholesalers provide the aforementioned information at the time of purchase or be in a position to provide this information at the time of a request. Such requests are being made despite pharmacies having purchased from duly, licensed, and verifiable wholesalers.”

Read the full source article:  The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt

Go to DREprof.com: The Designated Representative and Exemptee Training Website