...investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably...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 or do not...

...recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug"...

...where the 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.' . . . Defendants argue that the term 'safe' should be interpreted with reference not only to the inherent...

...time. Prior to 1962, sponsors of new drugs were required to prove only that their products would be safe for use under the conditions prescribed, recommended or suggested in the labeling. In making judgements as to safety, the Food and Drug Administration could and did insist...

...investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably...not such drug is safe for use under the conditions Erescribed, recommended, or suggested in the proposed ibeling thereof; (2) the results of such tests...

...investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably...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 or do not...

...reports of which are required to be submitted to the Secretary pursuant, to subsection (b), do nut include adequate tests by all methods reasonably applicable...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 or do not...

...reports of which are required to be 'submitted to" the Secretary pursuant to subsection (b) . . . , do not include adequate tests by all methods reasonably...use under the conditions prescribed, recommended, or suggested iu the proposed labeling thereof; (2) the results of such tests show that such drug is...

...where the 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 "safe"' should...

...investigations, reports of which are required t<> be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drag is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling...