...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 ecretary shall consider, among other relevant factors, (A) the probable consumption of...

...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 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...

...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";...

...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 tests show that such drug is unsafe tor use under such conditions...

...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"...

...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...

...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...

...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...

...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...