STAT May 13, 2024
Ed Silverman

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA.

For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry. Known as the Orange Book, it holds a key, behind-the-scenes role in shaping the competitive landscape...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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