 | 1979 - 1000 lapas
...evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying... | |
 | 1979 - 840 lapas
...information before the Food and Drug Administration, evaluated together with the evidence available when the application was approved, the labeling of the drug, based on a fair evaluation of all material DRUG SAFETY 83 facts, is false or misleading in any particluar ; and that the matter complained of... | |
 | 1979 - 968 lapas
...together with the evldencfe before him when the application was approved, the labeling of such drug, ba-ed on a fair evaluation of all material facts. Is false or misleading In any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying... | |
 | United States - 2004
...evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying... | |
 | 1985 - 976 lapas
...on the basis of new information before FDA, evaluated together with the evidence available when the application was approved, the labeling of the drug,...corrected by the applicant within a reasonable time 21 CFR Ch. I (4-1-85 Edition) after receipt of written notice from the agency. (4) That the applicant... | |
 | 1985 - 982 lapas
...information before the Food and Drug Administration, evaluated together with the evidence available when the application was approved, the labeling of the drug,...facts, is false or misleading in any particular; and that the matter complained of was not corrected by the applicant within a reasonable time after his... | |
 | 1990 - 1054 lapas
...on the basis of new infor mation before FDA, evaluated together with the evidence available when the application was approved, the labeling of the drug,...to comply with the notice requirements of section 510( j)(2) of the act. (5) That the applicant has failed to submit bioavailability or bioequivalence... | |
 | 1991 - 1218 lapas
...on the basis of new information before FDA, evaluated together with the evidence available when the application was approved, the labeling of the drug,...time after receipt of written notice from the agency. §314.152 (4) That the applicant has failed to comply with the notice requirements of section 510(j)(2)... | |
 | DIANE Publishing Company - 1994 - 226 lapas
...evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying... | |
| |
... drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under... 
