...definition of a "new drug" (21 US Code 321 (p)) is "any drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience ... as safe and effective . . . ." Until drugs made by recombinant DNA techniques become...

...not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; or (2) The result of such tests show that such drug Is unsafe for use under...

...the 1954 Act reads: "Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not generally recognized, among experts qualified...training and experience to evaluate the safety of pesticide chemicals as safe for use ... shall be deemed unsafe . . . unless . . . ." 21 USC § 346a(l)...

...Conditions of safety. Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not generally recognized, among experts qualified...training and experience to evaluate the safety of pesticide chemicals, as safe for use, added to a raw agricultural commodity, shall be deemed unsafe...

...drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the...

...1962, it was commercially used or sold in Uie United States. i2< On October 9, 1962. It was Bent-rally recognized, among experts qualified by scientific training and experience to evaluate the safety of iirugs. as safe for use m the cure, mitigation, treatment, or prevention of cancer in man: <3> On October...

...data submitted by the applicant and otherwise available to FDA are adequate to show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proi>osed labeling. 21 USC §300b(d) (1) (A), and (B) ; 21 USC §360b(d)(2). Once a new animal drug...

...not include "adequate tests by all methods reasonably applicable to show whether or not [the] drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;" C 2) the results of these tests show that the drug 1s "unsafe for use under...

...the Food, Drug, and Cosmetic Act prohibits Interstate shipment of a "new drug" — that is, one that is not generally recognized among experts qualified...conditions prescribed, recommended, or suggested In the labeling thereof or one that has not been used to a material extent or for a material time other than...

...with the body, (p) The term "new drug" means — (I) Any drug the composition of which is such that such drug is not generally recognized, among experts...safety of drugs, as safe for use under the conditions proscribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized...