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FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities | Alston & Bird

FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities | Alston & Bird
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COVID-19 Medical Products Supply Chain Week in Review – March 2021 #2 | Alston & Bird

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In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO issued a report on the FDA’s inspection challenges. Please see details for these supply chain developments below:
On March 2, President Biden announced that Johnson & Johnson and Merck will cooperate to expand the production of the Janssen vaccine, and the Administration invoked the DPA to equip two Merck facilities to meet the standards necessary to manufacture the vaccine. He added that the Administration will continue to use the DPA to expedite critical materials in vaccine production, such as equipment, machinery, and supplies. He projected that the U.S. is on track to have enough vaccine supply for every adult in the U.S. by the end of May. ....

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Washington Healthcare Update - March 2021 #2 | McGuireWoods Consulting

340B: 266 House Legislators Want Fines for Drug Companies
Two hundred sixty-six members of the House of Representatives have told the Department of Health and Human Services that HHS should fine drug companies that deny 340B discounts to hospitals for drugs dispensed by contract pharmacies and to make drug companies pay hospitals back for discounts that were withheld. The letter says it’s the long-held position of the Health Resources and Services Administration that drug companies must provide 340B discounts to hospitals and clinics that qualify, regardless of whether hospitals dispense the drugs themselves. The letter states there are no provisions in the statute that allow manufacturers to set conditions or impede access to 340B discounts. ....

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