7-Year Market Exclusivity for Orphan Drugs: Benefits and Pitfalls
7-Year Market Exclusivity for Orphan Drugs: Benefits and Pitfalls Exploring the Advantages and Limitations of 7-Year Exclusivity for Orphan Drugs Understanding the Orphan Drug Act and Market Exclusivity Provision The U.S. Orphan Drug Act (ODA) of 1983 was enacted to stimulate the development of therapies for rare diseases — defined as conditions affecting fewer than…
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