 | Administrative law - 1997 - 1166 pages
...abbreviated application for a new drug under section 505(j) of the act for any of the following reasons: (1) The methods used in, or the facilities and controls...for, the manufacture, processing, and packing of the irug product are inadequate to ensure and preserve its identity, strength, Quality, and purity. (2)... | |
 | United States - Social security - 2003 - 992 pages
...information before him, evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity,... | |
 | Administrative law - 1964 - 1248 pages
...Drug Administration, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; or (3) That on the... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 850 pages
...Drug Administration, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity : or facts, is false... | |
 | 2002 - 129 pages
...paragraph (5), the Secretary shall approve an application for a drug unless the Secretary finds (A) the methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; (B) information... | |
 | Administrative law - 1972 - 736 pages
...manufacturing practice. The criteria in §§ 133.201-210, inclusive, shall apply in determining whether the methods used in, or the facilities and controls used for the manufacture, processing, packing, or holding of a medicated premix conform to or are operated or administered... | |
 | Administrative law - 1971 - 704 pages
...manufacturing practice. The criteria in §§ 133.201-210, inclusive, shall apply in determining whether the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or holding of a medicated premix conform to or are operated or administered... | |
 | 67 pages
...such device, evaluated together with the evidence before him when the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such device do not conform with the requirements... | |
 | Administrative law - 1968 - 636 pages
...manufacturing practice. The criteria in §§ 133.101-133.110, inclusive, shall apply in determining whether the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or holding of a medicated feed conform to or are operated or administered... | |
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... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of... 
