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" A statement of the methods, facilities, and controls used for the manufacturing, processing, and packing of the new drug to establish and maintain appropriate standards of identity, strength, quality, and purity as needed for safety and to give significance... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 55
1979
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Code of Federal Regulations: Containing a Codification of Documents of ...

1978 - 860 pages
...notice of claimed investigational exemption for a new drug under the provisions of section 505(1) of the Federal Food, Drug, and Cosmetic Act and § 312.1...information available to the sponsor derived from pre¿ clinical investigations and any clinical studies and experience with the drug as follows: a....
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Code of Federal Regulations: Containing a Codification of Documents of ...

1965 - 1520 pages
...including the name and address of each supplier or processor, other than the sponsor, of each new-drug substance. 5. A statement of the methods, facilities,...information available to the sponsor derived from preclinlcal Investigations and any clinical studies and experience with the drug as follows: a. Adequate...
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The Code of Federal Regulations of the United States of America

1964 - 1242 pages
...name and address of each supplier or processor, other than the sponsor, of each new-drug substance. 6. A statement of the methods, facilities, and controls...information, available to the sponsor derived from preclinlcal investigations and any clinical studies and experience with the drug as. follow: ; ; a....
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Code of Federal Regulations: Containing a Codification of Documents of ...

1981 - 1258 pages
...controls used for the manufacturing, processing, and packing of the investigational drug are inadequate to establish and maintain appropriate standards of...significance to clinical investigations made with the drug; or (6) The plan for clinical investigations of the drugs described under section 10 of the "Notice...
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The Code of Federal Regulations of the United States of America

1971 - 676 pages
...name and address of each supplier or processor, other than the sponsor, of each new-drug substance. 6. A statement of the methods, facilities, and controls...the new drug to establish and maintain appropriate standard« of identity, strength, quality, and purity as needed for safety and to give significance...
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Drug Industry Act of 1962: Hearings ... Eighty-seventh Congress, Second ...

United States. Congress. House. Committee on Interstate and Foreign Commerce - 1962 - 734 pages
...of each supplier or processor, other than the undersigned, of each new-drug substance. "5. A brief statement of the methods, facilities, and controls...identity, strength, quality, and purity as needed to give significance to clinical investigations made with the drug. If any of these operations are...
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Drug Industry Act of 1962, Hearings ... 87-2 ... June 19, 20, 21, 22, August ...

United States. Congress. House. Interstate and Foreign Commerce - 1962 - 732 pages
...of each supplier or processor, other than the undersigned, of each new-drug substance. "5. A brief statement of the methods, facilities, and controls...identity, strength, quality, and purity as needed to give significance to clinical investigations made with the drug. If any of these operations are...
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Drug Safety: Hearings Before a Subcommittee of the Committee on Government ...

United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...address of each supplier or processor, other than the undersigned, of each new-drug substance. 5. A brief statement of the methods, facilities, and controls...identity, strength, quality, and purity as needed to give significance to clinical investigations made with the drug. If any of these operations are...
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Competitive Problems in the Drug Industry, Volume 14

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1969 - 460 pages
...name and address of each supplier or processor, other than the sponsor, of each new-drug substance. 6. A statement of the methods, facilities, and controls...Information available to the sponsor derived from precllnlcal Investigations and any clinical studies and experience with the drug as follows : a. Adequate...
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FDA Papers, Volume 5

1971 - 578 pages
...(see next section). Part 5: Methods, facilities, and controls used for the manufacture and processing of the new drug to establish and maintain appropriate...purity as needed for safety and to give significance to the clinical investigations made with the drug. a. Raw Material Controls: 1. New Drug Substance: Controls...
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