...nut 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; (B) the results of such tests show that such drug is unsafe for use under such conditions...

...reports of the investigations submitted do not include adequate tests showing whether the new drug is "safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof." 21 USC g355(d) (1). See also 21 USC §355(d) (2) and (4). Defendants argue that the term...

...reports include adequate tests by all methods reasonably accurate to show whether or not the drug is safe for use under the conditions prescribed, recommended or suggested in the proposed labeling for it. 2. That the results of such tests show that the drug is safe for use. 3. That FDA has sufficient...

...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; (B) the results of such tests show that such drug is unsafe for use under such conditions...

...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; (B) the results of such tests show that such drug is unsafe for use under such conditions...

...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 such conditions...

...not apply, he shall issue an order approving the application. (2) In determining whether such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among other relevant factors, (A) the probable consumption of...

...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 such conditions...

...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 such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such test* show that sicn drug is unsafe for jse under such conditions...