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" Records and reports concerning experience on drugs for which an approval is in effect. (a) On receiving notification that an application for a new drug is approved, the applicant shall establish and maintain records and make reports that are necessary... "
Use of Advisory Committees by the Food and Drug Administration: Hearings ... - Page 240
by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1974
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1979
...§310.300 Record* and report* concerning experience on drugs for which an approval ia in effect. (a) On receiving notification that an application for...application, including adequately organized and indexed files containing full reports of any of the following kinds of information, pertinent to the safety...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1981
...310.300 Records and reports concerning experience on drugs for which an approval is in effect. (a) On receiving notification that an application for...application, including adequately organized and indexed files containing full reports of any of the following kinds of information, pertinent to the safety...
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The Code of Federal Regulations of the United States of America

Administrative law - 1964
...§ 130.13 Records and reports concerning experience on drugs for which an approval is in effect. (a) On receiving notification that an application for...whether there may be grounds for invoking section 505 (e) of the act to suspend or withdraw approval of the application, including adequately organized...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1983
...310.300 Records and reports concerning experience on drugs for which an approval is in effect. (a) On receiving notification that an application for...facilitate a determination whether there may be grounds for inyokIng section 505(e) of the act to suspend or withdraw approval of the application, including adequately...
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Code of Federal Regulations

Administrative law - 1965
...concerning experience on drugs for whkt an approval is in effect. (a) On receiving notification that sr application for a new drug is approved the applicant...establish and maintain records and make reports that an necessary to facilitate a determinatioc whether there may be grounds for Invoking section 505 (e)...
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The Code of Federal Regulations of the United States of America

Administrative law - 1971
...are necessary to facilitate a determination whether there may be grounds for invoking section 505 (e) of the act to suspend or withdraw approval of the...application, including adequately organized and indexed files containing full reports of any of the following kinds of information, pertinent to the safety...
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The Code of Federal Regulations of the United States of America

Administrative law - 1974
...Not specified. 21 CFR 146.14 2.17 Persons holding approved new-drug applications. To maintain records necessary to facilitate a determination whether there...may be grounds for invoking section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 USC 355(e)) to suspend or withdraw approval of the application....
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The Code of Federal Regulations of the United States of America

Administrative law - 1967
...application for a new drug is approved, establish and maintain such records and make such reports as are necessary to facilitate a determination whether there may be grounds for invoking section 505 (e) of the Federal Food, Drug, and Cosmetic Act to suspend or withdraw approval of the application....
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The Code of Federal Regulations of the United States of America

Administrative law - 1973
...specified. 21 CFR 146.14 2.17 Persons holding approved new-drug applications. [Amended] To maintain records necessary to facilitate a determination whether there may be grounds for invoking section 505 (e) of the Federal Food, Drug, and Cosmetic Act (21 USC 355(eģ to suspend or withdraw approval...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1967
...application for a new drug is approved, establish and maintain such records and make such reports as are necessary to facilitate a determination whether there may be grounds for inyoking section 505(e) of the Federal Food, Drug, and Cosmetic Act to suspend or withdraw approval...
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