| 1989 - 464 pages
...reports of adequate clinical investigations; that FDA had announced that the exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 did not apply to antibiotic drugs; that Glaxo disputed such announced FDA interpretation and petitioned... | |
| 1985 - 466 pages
...functions assigned to the Food and Drug Administration. (27) Functions vested in the Secretary under Title II of the Drug Price Competition and Patent Term Restoration Act of 1984 (35 USC 156), which allows for the extension of patent terms for human drug products, medical devices,... | |
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