...drugs and two medical devices are the first products to be granted patent extensions under provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. The products and the length of their extensions are: • Ridaura, an anti-arthritic drug— two years •...

...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...

...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,...

...requirements and approved between 1938 and 1982 (the years of 1962 to 1982 have been added with the passage of the Drug Price Competition and Patent Term Restoration Act of 1984) are effective as well as safe; and to ensure that identical and acceptably similar and related product*...

...Administration's progress in implementing a most important change in our drug laws. This change is the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, now commonly referred to as the Waxman-Hatch amendments. These amendments revised the procedures for...

...because "Paper NDAs" were transferred from New Drug Evaluation to Generic Drug Evaluation as a result of the Drug Price Competition and Patent Term Restoration Act of 1984. 2/ Workload indicators have been changed to better reflect submissions received and review procedures....

...years With Patent Term Extension 22 years Bolar/Roche Cost of Time 5-7 years 29 years In section 202 of the Drug Price Competition and Patent Term Restoration Act of 1984 provisions were included to overrule the Bolar/Roche Decision. Essentially those provisions stated...

...research unless a workable mechanism is established to enforce the marketing exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. At the present time, there is no means of ensuring that once subjected to generic competition the pioneer...

...is where the major data development and review occur. In the long and arduous process leading up to the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, many compromises and accommodations were agreed to by the various parties involved. One of the compromises...

...is where the major data development and review occur. In the long and arduous process leading up to the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, many compromises and accommodations were agreed to by the various parties involved. One of the compromises...