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
... unless such uses are directed by a physician . ( viii ) If the article is offered for use in arthritis or rheumatism , the label- ing prominently bears a statement that the beneficial effects claimed are limited to the temporary relief ...
... unless such uses are directed by a physician . ( viii ) If the article is offered for use in arthritis or rheumatism , the label- ing prominently bears a statement that the beneficial effects claimed are limited to the temporary relief ...
17. lappuse
... unless directed by a physician . ( vii ) The labeling bears , in juxtaposi- tion with the directions for use , clear warning statements against : ( a ) Prolonged use . ( b ) Application to large areas of the body . ( c ) Continued use ...
... unless directed by a physician . ( vii ) The labeling bears , in juxtaposi- tion with the directions for use , clear warning statements against : ( a ) Prolonged use . ( b ) Application to large areas of the body . ( c ) Continued use ...
18. lappuse
... unless directed by a physician . ( vii ) The labeling bears , in juxtaposi- tion with the directions for use , a clear warning statement , such as : " Caution : If redness , irritation , swelling , or pain persists or increases ...
... unless directed by a physician . ( vii ) The labeling bears , in juxtaposi- tion with the directions for use , a clear warning statement , such as : " Caution : If redness , irritation , swelling , or pain persists or increases ...
19. lappuse
... unless directed by a physician , and against driving a car or operating machinery while using the drug , since it may cause drowsi- ness . ( b ) If the article is offered for the temporary relief of symptoms of colds , a statement that ...
... unless directed by a physician , and against driving a car or operating machinery while using the drug , since it may cause drowsi- ness . ( b ) If the article is offered for the temporary relief of symptoms of colds , a statement that ...
24. lappuse
... unless the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience . ( 2 ) Each person identified in paragraph ( c ) ( 1 ) of this section shall submit one copy of each report to the ...
... unless the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience . ( 2 ) Each person identified in paragraph ( c ) ( 1 ) of this section shall submit one copy of each report to the ...
Saturs
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761 | |
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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