 | United States - 1977 - 1276 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... | |
 | 1998 - 1162 lapas
...approved, the methods used in, or Food and Drug Administration, HHS the facilities and controls used for, the manufacture, processing, and packing of the...to comply with the notice requirements of section 5100X2) of the act. (5) That the applicant has failed to submit bioavallability or bioequivalence data... | |
 | 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,...to comply with the notice requirements of section 510CJX2) of the act. (5) That the applicant has failed to submit bioavailability or bioequivalence... | |
 | 1998 - 1120 lapas
...evaluated together with the evidence available when the application or abbreviated application «u approved, the labeling of the drug, based on a fair...to comply with the notice requirements of section 51<Xj)(2) of the act. (5) That the applicant has failed to «nbmit bloavailability or bioequlvabce... | |
 | 1998 - 1120 lapas
...evaluated together with the evidence available when the application or abbreviated application «u approved, the labeling of the drug, based on a fair...to comply with the notice requirements of section 51<Xj)(2) of the act. (5) That the applicant has failed to «nbmit bloavailability or bioequlvabce... | |
 | 1981 - 1252 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... | |
 | 2002 - 628 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... | |
 | 2006 - 616 lapas
...together with the evidence before him when such license was issued, the labeling of any animal feeds, 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 Commissioner specifying... | |
 | 1988 - 772 lapas
...the evidence before him when the application was approved, the labeling of such drug or animal feed, 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... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 lapas
...information before the Food and Drug Administration, evaluated together with the evidence available when the application was approved, the labeling of the drug,...all material facts, is false or misleading in any particluar ; aud that the matter complained of was not corrected by the applicant within a reasonable... | |
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... 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... 
