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" Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects,... "
Code of Federal Regulations: Containing a Codification of Documents of ... - 21. lappuse
2001
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The Code of Federal Regulations of the United States of America

1967 - 406 lapas
...opinion on a proposal to omit such information from the dispensing package under this proviso. (4) Any labeling, as defined in section 201(m) of the...This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications...
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The Code of Federal Regulations of the United States of America

1964 - 1242 lapas
...information from the dispensing package under this proviso. (4) Any labeling, as defined in section 201 (m) of the act, whether or not It Is on or within a package...This Information will not be required on so-called reminder-piece labeling which calls attention to thé name of the device but does not Include indications...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1961 - 674 lapas
...Subparagraph (1) amended, 25 FR 12594, Dec. 9, 1960] ***** (4) Any labeling, as denned in section 20 Km) of the act, whether or not it is on or within a package...This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications...
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The Code of Federal Regulations of the United States of America

1999 - 724 lapas
...(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods,...precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 200 lapas
...is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and fre-quency and duration of administration,...precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including...
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The Code of Federal Regulations of the United States of America

1992 - 744 lapas
...proposed fails to bear adequate information for professional use including indications, effects, dosages, routes, methods, and frequency and duration of administration...precautions under which practitioners licensed by law to administer such drug can use the drug for the purposes for which it is intended, including all purposes...
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Drug Industry Antitrust Act: Hearings Before the Subcommittee on ..., 5-6. daļas

United States. Congress. Senate. Committee on the Judiciary - 1961 - 754 lapas
...(3) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods,...precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including...
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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 lapas
...in the course of his professional practice. ******* (4) Any labeling, as defined in section 201 (m) of the act, whether or not it is on or within a package...represented. This information will not be required ou so-called reminder-piece labeling which calls attention to the name of the device but does not include...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1966 - 2114 lapas
...to omit such information from the dispensing package under this proviso. (4) Any labeling, as denned in section 201(m) of the act, whether or not it is...This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications...
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Competitive Problems in the Drug Industry: Hearings, Ninetieth Congress ...

United States. Congress. Senate. Select Committee on Small Business. Committee on Monopoly - 1975 - 484 lapas
...prescription drug shall contain adequate information for use including indications, effects, dosages, routes, methods and frequency and duration of administration...precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purpose for which it is intended and, if the...
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