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FDA Finalizes Guidance On Interpretation Of Orphan Drug “Sameness” For Gene Therapy Products

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more

Vaccine Production And State Intervention In The U.S.

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

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