| United States. Patent Office - 1964 - 972 páginas
...Is safe for use under such conditions; (3) the methods used In, and the facilities and controls used for, the manufacture, processing, and packing of such drug are Inadequate to preserve Its Identity, strength, quality, and purity; or (!) upon the basis of the Information submitted... | |
| 1939 - 1496 páginas
...is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; or (4) upon the basis of the information submitted... | |
| United States - 1977 - 1276 páginas
...verification of, such records as required by subparagraph (B) of such paragraph; (ii) that on the basis of new information before him, evaluated together with the evidence before him when such application was approved, the methods used in, or the facilities and controls used for, the manufacture,... | |
| United States - 1964 - 1098 páginas
...is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; (4) upon the basis of the information submitted... | |
| 1999 - 596 páginas
...of, such records as required by section 512(1)(2) or (m)(5)(B) of the act; or (2) That on the basis of new information before him evaluated together with...manufacture, processing, and packing of such drug or animal feed are inadequate to assure and preserve its identity, strength, quality, and purity and... | |
| 2000 - 698 páginas
...section 512(w) of the act; or (2) That on the basis of new information before him evaluated togetber with the evidence before him when the application...manufacture, processing, and packing of such drug or animal feed are inadequate to assure and preserve its identity, strength, quality, and purity and... | |
| 1996 - 618 páginas
...of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him, evaluated together...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... | |
| 1990 - 782 páginas
...of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him, evaluated together...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... | |
| 1981 - 1252 páginas
...information before the Food and Drug Administration, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity,... | |
| 1979 - 1056 páginas
...information before the Food and Drug Administration, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity,... | |
| |