Hatch Act

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

Drugs Under Patent. This book [77] is a cross-referenced listing of over 2500 drugs covered in the United States under patent law and marketing exclusivity provisions of the Waxman-Hatch Act. Eight indexes provide market and patent status information by company, trade name, generic name, expiration date, dosage form, exclusivity code, patent number, and NDA number. Updated annually, this book is available commercially. 

Hassium (Hs), l 492t HASTELLOY alloys, 17 102, 103 Hastelloy B, 13 519 Hastelloy B-2, 23 784-785 Hastelloy-C, 14 14 Hastelloy C series alloys, 13 520 Hatch Act of 1887, 24 353-354 Hatta number, 21 345 Haulage distances, 15 60-61 Hausmannite, 15 540 Hayashi-Williams equation, 22 561 Haylage, 10 863... 

New Jersey Agricultural Experiment Station Publication Number F-01112-01-86 supported by State and U. S. Hatch Act Funds. 

Grabowski, H. and Vernon, J. (1996) Longer patents for increased generic com-petion in the US the Waxman-Hatch act after one decade. Pharmacoeconomics 10, 110-123. 

This research was supported in part by grants from the U.S. Department of Agriculture (87-CRCR-1-2414), the Charles and Johanna Busch Foundation, and the New Jersey Agricultural Experiment Station with State and Hatch Act funds. New Jersey Agricultural Experiment Station, Publication No. F-10546-1-88. We thank Mrs. Marianne Bianco for assisting with manuscript preparation. 

Grabowski, Henry, and John Vernon. 1996. Longer Patents for Increased Generic Competition The Waxman-Hatch Act after One Decade. PharmacoEconomics 10 (Suppl. 2) 110-123. 

This is publication No. D-10100-24-88 of the New Jersey Agricultural Experiment Station, supported by State funds and U. S. Hatch Act funds. The authors are grateful to Robert Trenkle and IFF for technical support in spectrometric analyses, and to Bristol-Myers USONG for their support in preparation of the manuscript. 

The Waxman-Hatch Act of 1984 was motivated, to a significant degree, by cost considerations, but quality issues concerning bioequivalency and therapeutic equivalency were addressed as well. All FDA-approved drugs (pioneer brand-name and generic versions) are required to meet the same FDA standards of quality. 

In 1984, President Reagan signed into law the Drug Price Competition and Patent Term Restoration Act (Waxman Hatch Act). This legislation created a system... 

In the United States, the situation was revolutionized by the Waxman-Hatch Act of 1984. Generics companies were granted the right to market out-of-patent drugs under their generic names, without having to repeat all the tests performed by the originator. Instead, they were able to submit an... 

I thank C. W. Holyoke, Jr., J. G. Hollingshaus, I. M. McDougall, and W. K. Moberg for discussions and helpful comments. This is New Jersey Agricultural Experiment Station Publication No. D-08111-32-88, supported by state funds and U. S. Hatch Act funds. 

Price Competition and Patent Restoration Act (Waxman-Hatch Act)... 

All officers, agents, attorneys, and employees of the Conunission shall be subject to the provisions of section 7324 of Title 5 [originally, section 9 of the Act of August 2, 1939, as amended (the Hatch Act)], notwithstanding any exemption contained in such section. 

A contribution of the University of Nebraska Agricultural Research Division, supported in part by funds provided through the Hatch Act. Additional support was provided by NIH grants DK063945, DK077816 and DK082476. 

Partial financial support for diis project was provided by the Center for Health Effects of Environmental Contaminants (CHEEC) at Ae University of Iowa. This journal paper of die Iowa Agriculture and Home Economics Experiment Station, Ames, Iowa, Project No. 3187, was siquported by Hatch Act and State of Iowa funds. 

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