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" For the purposes of paragraph (2)(B), the term "due diligence" means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. "
Lopid Patent Term Restoration and Fairness Act of 1987: Hearing Before the ... - Page 244
by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice - 1988 - 350 pages
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The Code of Federal Regulations of the United States of America

1994 - 446 pages
...applicant's actions during the regulatory review period to determine whether the applicant exhibited that degree of attention, continuous directed effort,...exercised by, a person during a regulatory review period. FDA will take into consideration all relevant factors, such as the amount of time between the approval...
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The Code of Federal Regulations of the United States of America

1995 - 440 pages
...applicant's actions during the regulatory review period to determine whether the applicant exhibited that degree of attention, continuous directed effort,...exercised by, a person during a regulatory review period. FDA will take into consideration all relevant factors, such as the amount of time between the approval...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 468 pages
...that degree of attention, continuous directed effort, and ยง60.30 Food and Drug Administration, HHS timeliness as may reasonably be expected from, and...exercised by, a person during a regulatory review period. FDA will take into consideration all relevant factors, such as the amount of time between the approval...
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Agriculture, rural development, and related agencies appropriations ..., Part 3

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies - 1985 - 1124 pages
...Commissioner of Fooo and Drugs. "(3) For the purposes of paragraph (2KB), the term 'due diligence' means that degree of attention, continuous directed effort,...exercised by, a person during a regulatory review period. "(4) An application for the extension of the term of a patent is subject to the disclosure requirements...
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Agriculture, rural development, and related agencies appropriations ..., Part 3

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies - 1985 - 888 pages
...in the Federal Register. "'3) For the purposes of paragraph < 2xB). the term 'due diligence' means that degree of attention, continuous directed effort,...ordinarily exercised by, a person during a regulatory ieview period. "'4) An application for the extension of the term of a patent is subject to the disclosure...
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Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1986 ...

United States. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry - 1986 - 216 pages
...involving the infringement of a patent. (E) For purposes of this paragraph, the term "due diligence" means that degree of attention, continuous directed effort,...exercised by, a person during a regulatory review period. (F) In a proceeding under this paragraph, the Administrator may take into consideratioin the failure...
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Compilation of selected acts within the jurisdiction of the Committee on ...

United States - 1987 - 526 pages
...of a drug if the applicant has demonstrated that degree of attention and continuous directed effort as may reasonably be expected from, and are ordinarily exercised by, a person before approval or licensing of a drug, such as the preparation for and the conduct of preclinical...
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The Code of Federal Regulations of the United States of America

1995 - 850 pages
...applicant's actions during the regulatory review period to determine whether the applicant exhibited the degree of attention, continuous directed effort, and...exercised by, a person during a regulatory review period. APHIS will take into consideration all relevant factors, such as the amount of time between the approval...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1989 - 464 pages
...applicant's actions during the regulatory review period to determine whether the applicant exhibited that degree of attention, continuous directed effort,...exercised by, a person during a regulatory review period. FDA will take into consideration all relevant factors, such as the amount of time between the approval...
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Patent Term Extension Legislation: Hearing Before the Subcommittee on ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Intellectual Property and Judicial Administration - 1993 - 474 pages
...defines "due diligence" a* "that degree of attention, continuous directed effort, and timeliness as say reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period." The purpose of the due diligence provision is to ensure that patent holders are not compensated for...
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