Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
1.–5. rezultāts no 100.
13. lappuse
... statement quoted in sec- tion 503 ( b ) ( 4 ) of the act , in the labeling of a drug exempted under the provi- sions of this section , constitutes mis- branding . Any other statement or sug- gestion in the labeling of a drug ex- empted ...
... statement quoted in sec- tion 503 ( b ) ( 4 ) of the act , in the labeling of a drug exempted under the provi- sions of this section , constitutes mis- branding . Any other statement or sug- gestion in the labeling of a drug ex- empted ...
15. lappuse
... statements against administration of the drug to children under 6 years of age , except as directed by a physician , and ... statement that continued adminis- tration for such use should not exceed 3 days , except as directed by a physi ...
... statements against administration of the drug to children under 6 years of age , except as directed by a physician , and ... statement that continued adminis- tration for such use should not exceed 3 days , except as directed by a physi ...
19. lappuse
... statement against administration of the drug to children under 6 years of age , unless di- rected by a physician . ( b ) A clear warning statement to the effect that frequent or prolonged use may cause nervousness , restlessness , or ...
... statement against administration of the drug to children under 6 years of age , unless di- rected by a physician . ( b ) A clear warning statement to the effect that frequent or prolonged use may cause nervousness , restlessness , or ...
25. lappuse
... statement that the applicant will initiate recall of all stocks of the drug product outstanding when so re- quested by the Food and Drug Adminis- tration . ( vii ) A statement that the applicant intends to conduct in vivo bio ...
... statement that the applicant will initiate recall of all stocks of the drug product outstanding when so re- quested by the Food and Drug Adminis- tration . ( vii ) A statement that the applicant intends to conduct in vivo bio ...
33. lappuse
... statement concerning the effectiveness of oral contraceptives in preventing preg- nancy , the contraindications to the drug's use , and a statement of the risks and benefits associated with the drug's use . ( 3 ) A statement comparing ...
... statement concerning the effectiveness of oral contraceptives in preventing preg- nancy , the contraindications to the drug's use , and a statement of the risks and benefits associated with the drug's use . ( 3 ) A statement comparing ...
Saturs
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351 | |
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699 | |
761 | |
826 | |
865 | |
890 | |
911 | |
949 | |
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abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning