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
... labeling . A proposal to exempt a drug from the prescription - dispensing re- quirements of section 503 ( b ) ( 1 ) ... labeling of a drug exempted under the provi- sions of this section , constitutes mis- branding . Any other statement or ...
... labeling . A proposal to exempt a drug from the prescription - dispensing re- quirements of section 503 ( b ) ( 1 ) ... labeling of a drug exempted under the provi- sions of this section , constitutes mis- branding . Any other statement or ...
21. lappuse
... labeling for the drug product . This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling , but differ from the event because of greater se- verity or specificity . For example ...
... labeling for the drug product . This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling , but differ from the event because of greater se- verity or specificity . For example ...
39. lappuse
... labeling required by para- graph ( a ) of this section . Such labeling may be put into use without advance approval by the Food and Drug Admin- istration . [ 55 FR 18723 , May 4 , 1990 ] prod- § 310.516 Progestational drug ucts ; labeling ...
... labeling required by para- graph ( a ) of this section . Such labeling may be put into use without advance approval by the Food and Drug Admin- istration . [ 55 FR 18723 , May 4 , 1990 ] prod- § 310.516 Progestational drug ucts ; labeling ...
40. lappuse
... labeling with the product . The requirement that any progestational drug product be dispensed with patient labeling , as applied to physicians who dispense or administer the drug , will not be effec- tive for supplies in their ...
... labeling with the product . The requirement that any progestational drug product be dispensed with patient labeling , as applied to physicians who dispense or administer the drug , will not be effec- tive for supplies in their ...
119. lappuse
... Labeling . Any change in labeling , except one described in paragraph ( c ) ( 2 ) or ( d ) of this section . ( c ) Supplements for changes that may be made before FDA approval . An appli- cant shall submit a supplement at the time the ...
... Labeling . Any change in labeling , except one described in paragraph ( c ) ( 2 ) or ( d ) of this section . ( c ) Supplements for changes that may be made before FDA approval . An appli- cant shall submit a supplement at the time the ...
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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