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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. This comparison is misplaced.

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Are microtaggants the key to making medicines smarter?

pharmaphorum

The dramatic rise in online drug sales during the COVID-19 pandemic has increased the supply of counterfeit drugs, and many companies are now considering the addition of on-dose authentication for high-risk or high-value products. This had led to a corresponding rise in the supply of counterfeit drugs.

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New Sandoz Board of Directors appointed

The Pharma Data

She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company. Shamiram holds an AB from Smith College and Doctor of Medicine as well as a Master of Public Health, both from Emory University, U.S.A. Prior to that, he worked in multiple executive business and finance roles for Philips and KPMG.

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