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" be sterile which are adulterated within the meaning of 21 USC 351(a)(2)(B) in that the methods used in and the facilities and controls used for the manufacturing, processing, packing, or holding of said articles do not conform to and "
Hearings, Reports and Prints of the Senate Select Committee on Small Business - Stranica 16198
napisao/la United States. Congress. Senate. Select Committee on Small Business - 1978
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Code of Federal Regulations: Containing a Codification of Documents of ...

1972 - Broj stranica: 926
...control of the product. (An application may be refused unless It includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity in conformity...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1973 - Broj stranica: 402
...control of the product. An application may be refused unless It Includes adequate information showing that the methods used In, and the facilities and controls used for, the manufacturing. procemist and packaging of the new animal drug are adequate to preserve Its Identity, strength. quality,...
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Agriculture and Related Agencies Appropriations for Fiscal Year 1976 ...

United States. Congress. Senate. Committee on Appropriations - 1975 - Broj stranica: 1110
...control of the product. (An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, .processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity in conformity...
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Regulation of Diethylstilbestrol (DES), 1975: Joint Hearing Before the ...

United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health - 1975 - Broj stranica: 322
...control of the product. (An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity in conformity...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1976 - Broj stranica: 1046
...control of the product. (An application may be refused unless it includes adequate information showing that the methods used in. and the facilities and controls used for, the manufacturing, processing, and packaging of the drug are adequate to preserve Its Identity. strength, quality, and purity in conformity...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1976 - Broj stranica: 448
...control of the product. An application may be refused unless It includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1977 - Broj stranica: 584
...control of the product. An application may be refused unless it includes adequate Information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its Identity, strength, quality, and...
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Competitive Problems in the Drug Industry, Opseg 33

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1978 - Broj stranica: 998
...for introduction into interstate ..o:nner ce of articles of drugs which purport or are represented cj be sterile which are adulterated within the meaning...USC 351(a)(2)(B) in that the methods used in and the l : acilities and controls used for the manufacturing, processing, packing, or holding of said articles...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

1979 - Broj stranica: 840
...(An application may be incomplete or may be refused unless It includes adequate Information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging Of th¿ drug are adsquste to preserve its identity, strength, quality and purity In conformity...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1982 - Broj stranica: 1106
...control of the product. (An application may be refused unless it includes adequate Information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity in conformity...
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