In a 2022 annual report, the US Food and Drug Administration’s (FDA) Office of Generic Drugs stated it had approved 106 first generics— the introductory generic competitors of branded drugs. This month’s cover story investigates how the regulatory process for these first generics differs from other drugs, and whether the promise of significant cost savings to consumers has been fulfilled.
With two historic FDA approvals for RSV vaccines in the last two months, this issue’s lead interview addresses the pertinent question of access—how to ensure eligible individuals across the world get this vaccine. Also in this issue, our reporters explore how patients could benefit from managed access programs that connect patients to investigational drugs, recommendations to reduce drug shortages in the European Union, and more.
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By GlobalDataDon’t miss the special thematic supplement that inspects the evolving role of cybersecurity in the pharmaceutical industry.
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