...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...

...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...

...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...

...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...

...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...

...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...

...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...

...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...

...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...

...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...