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1.
Pharmaceutical Technology Europe ; 33(5):35-36, 2021.
Article in English | ProQuest Central | ID: covidwho-20242755

ABSTRACT

COVID-19 vaccines, approved under emergency use authorization, were not required to meet serialization requirements, but they have been properly labelled to meet US Food and Drug Administration (FDA) requirements, he says, complete with 2D barcodes with GTIN, lot, and expiry date. The company decided to serialize its Diprovan anesthetic, a workhorse generic product, using radio frequency identification tags containing the four identifiers (2). "If an agent is handling your product on your behalf, they need to leverage GS1 Standards including GTINs for products [and] global location numbers (GLNs) for physical locations, and share data electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.

2.
American Journal of Public Health ; 112(8):1110-1114, 2022.
Article in English | ProQuest Central | ID: covidwho-1958495

ABSTRACT

GOVERNMENT PATENT USE One way to facilitate public access to high-cost medications is through government patent use.1 Given sovereign immunity-a legal doctrine immunizing the government from being sued without its consent-the federal government and its agents, such as generic drug manufacturers, have the ability to make or use patented inventions without the permission of the patent holder;in other words, protected by sovereign immunity, the federal government could use inventors' US patents without legal consequence (US patent rights do not apply overseas). [...]nonpatent exclusivities generally prohibit the approval of competing products only if they rely on data generated by another manufacturer. [...]the government or any third party could submit full new drug applications with original data.1,2 This strategy would not be able to circumvent Orphan Drug Act exclusivity for rare disease drugs because that act blocks the FDA from approving the "same drug" for the same disease or condition if it is a generic;however, because full trials would be needed, it might be feasible to pursue approval of a chemically distinct but therapeutically identical drug. [...]many agency actions are judicially reviewable under the Administrative Procedure Act (1946, Pub L No. 79-404)-a statute that waives the federal government's sovereign immunity. Fourth, Congress could amend the Federal Food, Drug, and Cosmetic Act (1938, Pub L No. 75-717) and the Public Health Service Act (1944, Pub L No. 78-410) to carve out exceptions to existing nonpatent exclusivities for government use.1,8 Although an exception exists for biologics the Public Health Service prepares when the biologic is unavailable from the license holder,9 this kind of authority could be expanded in terms of both to whom and to what it applies as well as under what conditions.

3.
Mathematics ; 10(10):1723, 2022.
Article in English | ProQuest Central | ID: covidwho-1870945

ABSTRACT

The free-riding behavior of companies that do not act will bring losses to companies that provide services. A market consists of two secondary supply chains: manufacturers and retailers. Each supply chain can choose to adopt promotional strategies to expand its market demand. This paper constructs the centralized decision-making in the supply chain and the Nash game competition model between supply chains and primarily studies the impact of risk aversion and the free-riding coefficient on supply chain pricing, promotion strategy selection, and expected utility. We show that the supply chain with high-risk aversion has relatively low pricing, but the demand and a total expected utility are high. We also identify that, on the premise of the same risk aversion degree of the two supply chains, when the free-riding coefficient between the chains is small and equal, the supply chain tends to implement the promotion strategy. When consumers have the same preference for the products of two retailers, the pricing of the free-riding supply chain increases with the increase in the free-riding coefficient, while the supply chain with a promotion strategy is the opposite. Based on the numerical results, we further give the optimal one-way free-riding coefficient when the two supply chains have the same degree of risk aversion;when there is a bidirectional free-riding behavior in the market, competition among supply chains gradually tends to the first two scenarios.

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