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" ... new drug. (4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Страница 23
1956
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Code of Federal Regulations: Containing a Codification of Documents of ...

1956
...Stat. 1051, as amended; 21 USC 353) NOTE: Paragraph (f) (1) and (2) of 1.108 has been transferred to Part 130, as 130.1 (a). 1.109 New drugs; definition....201, 52 Stat. 1041, as amended; 21 USC 321) 1.109a New drugs; exemption from section 505 of the act. A new drug shall not be deemed to be subject to...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1979
...a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug. (i) "Animals used only for laboratory research" and "laboratory research animals" mean individual animals...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998
...new drug when used in another disease or to affect another structure or func-tion of the body. (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug. (1) [Reserved] (j) The term sponsor means the person or agency who assumes responsibility for an Investigation...
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The Code of Federal Regulations of the United States of America

2002
...a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug. (i) [Reserved] (j) The term sponsor means the person or agency who assumes responsibility for an investigation...
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Drug Safety: Hearings Before a Subcommittee of the Committee on Government ...

United States. Congress. House. Committee on Government Operations - 1964 - 2377 страница
...a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of...application, or different condition, Is not a new drug. 130.2 Biologies ; products subject to license control. A new drug shall not be deemed to be subject...
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National Commission on Health Science and Society: Hearings, Ninetieth ...

United States. Congress. Senate. Committee on Government Operations. Subcommittee on Government Research - 1968 - 533 страница
...a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug." (Drug Amendments of 1962. ) Specifically, materials introduced into interstate commerce become subject...
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Use of Advisory Committees by the Food and Drug Administration: Hearings ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1974 - 556 страница
...Section 310.3(h)(5) states "The newnesss of a drug may arise by reason (among other reasons) of: (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug." The Commissioner has reached this tentative conclusion because of the above noted safety issues in...
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Use of Advisory Committees by the Food and Drug Administration: Hearings ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1974
...Section 310.3(h)(5) states "The newnesss of a drug may arise by reason (among other reasons) of: (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug." The Commissioner has reached this tentative conclusion because of the above noted safety issues in...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1976
...a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of...application, or different condition, is not a new drug. (i) "Animals used only for laboratory research" and "laboratory research animals" mean individual animals...
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Drugs in Institutions: Hearings Before the Subcommittee to ..., Том 3

United States. Congress. Senate. Committee on the Judiciary. Subcommittee to Investigate Juvenile Delinquency - 1977
...affect another structure or function of the body.32/ 32/ Additionally, 21 CFR S 310.3(h)(5) provides: The newness of a dosage, or method or duration of...application, or different condition, is not a new drug. - 18 The FDA has also acknowledged its responsibility with respect ' to the unapproved use of new drugs...
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