...investigations and reports do not include adequate tests, by all methods reasonably applicable, to see whether or not the drug is safe for use under the conditions set forth in its labeling; or if, on the basis of the, new drug application, or any other available...

...that an NDA contain full reports of adequate preclinical tests by all methods reasonably applicable to show whether or not the drug is safe for use under the conditions prescribed, recormended, or suggested in the proposed labeling. The reports are to include all studies made on...

...Investigations submitted to the Agency do not include "adequate tests by all methods reasonably applicable to show whether or not [the] drug is safe for use...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...

...determine whether 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...

...observe these requirements of the Act, It U obvions that FDA must make the following findings liefore approving an NDA : 1. The applicant submitted full...results of such tests show that the drug Is safe for nee. 3. That FDA has sufficient information to determine that the drug Is safe for use. 4. That there...

...(b), do not include adequate tests by all methods reasonably applicable to show whether nr not such drug is safe for use under the conditions prescribed,...recommended, or suggested in the proposed labeling thereof; "(H) the results of such tests show that such drug is unsafe for use under such conditions...

...(H) do 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...

...section, do 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 for use under such conditions...

...market the product CARISOPKOOOL until the parties have mutually agreed tbat said product CAHISOPRODOL is safe for use under the conditions prescribed, recommended or suggested in the proposed labelling for the product, and will not market the product CARISOPKODOL, without the written approval...

...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 or one that has not been used to a material extent or for a material time other than...