...Federal Food, Drug, and Cosmetic Act approved June 25, 1938 (52 Stat. 1040 et seq., as amended; 21 USC 301-392). (b) "Department" means the Department of...Biologies; products subject to license control. (a) A new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under...

...in this part. (g) "New-drug substance" means any substance that when used in the manu130.3 facture, processing, or packing of a drug, causes that drug...application, or different condition, is not a new drug. (i) "Animals used only for laboratory research" and "laboratory research animals" mean Individual animals...

...Administration charged with the administration of section 505 of the act relating to new drugs. (f) The newness of a drug may arise by reason (among other...application, or different condition, is not a new drug. (g) "New-drug substance" means any substance that, when used in the manufacture, processing, or packing...

...composes such drug, in whole or in part, whether it be an active substance or a menstruum, cxcipient, carrier, coating, or other component. (2) The newness...application, or different condition, is not a new drug. (g) "New-drug substance" means any substance that, when used in the manufacture, processing, or packing...

...active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more substances,...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...

...active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more sub-stances,...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...

...active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more substances,...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...

...combination, even though such combination containing1 such substance in other proportion is not a new drug1. (4) The newness of use of such drug in diagnosing,...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...

...Is not a new drug. 1 4) The newness of use of such drug in diagnosing, curing, mitigating, treatins, or preventing a disease, or to affect a structure...application, or different condition, is not a new drug. (1) "Animals used only for laboratory research" and "laboratory research animals" mean individual animals...

...curing, mitigating, treating, or preventing a disease, or to affect a structure or function of trie body, even though such drug is not a new drug when...application, or different condition, is not a new drug. (1) "Animals used only for laboratory research" and "laboratory research animals" mean Individual animals...