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
6.–10. rezultāts no 100.
24. lappuse
... prescription drug product as its manufacturer , packer , or dis- tributor shall report to FDA each adverse drug experience received or otherwise ob- tained that is both serious and unexpected as soon as possible but in any case within ...
... prescription drug product as its manufacturer , packer , or dis- tributor shall report to FDA each adverse drug experience received or otherwise ob- tained that is both serious and unexpected as soon as possible but in any case within ...
25. lappuse
... drug product under section 505 ( e ) of the act . Marketing of these products may be continued only under the following conditions : ( 1 ) Digoxin products for oral use , other than tablets : Any person market- ing digoxin products for ...
... drug product under section 505 ( e ) of the act . Marketing of these products may be continued only under the following conditions : ( 1 ) Digoxin products for oral use , other than tablets : Any person market- ing digoxin products for ...
33. lappuse
... drug products requires that patients be fully informed of the benefits and the risks involved in their use . An oral contraceptive drug prod- uct that does not comply with the ... drug product 33 Food and Drug Administration , HHS $ 310.501.
... drug products requires that patients be fully informed of the benefits and the risks involved in their use . An oral contraceptive drug prod- uct that does not comply with the ... drug product 33 Food and Drug Administration , HHS $ 310.501.
34. lappuse
... drug product . ( e ) Labeling guidance texts . The Food and Drug Administration issues infor- mal labeling guidance texts under §10.90 ( b ) ( 9 ) of this chapter to provide assistance in meeting the requirements of this section . A ...
... drug product . ( e ) Labeling guidance texts . The Food and Drug Administration issues infor- mal labeling guidance texts under §10.90 ( b ) ( 9 ) of this chapter to provide assistance in meeting the requirements of this section . A ...
38. lappuse
... drug product for intra- venous use in humans that is packaged in a plastic immediate container on or after April 16 , 1979 , is misbranded un- less its labeling contains a warning that includes the following informa- tion : ( 1 ) A ...
... drug product for intra- venous use in humans that is packaged in a plastic immediate container on or after April 16 , 1979 , is misbranded un- less its labeling contains a warning that includes the following informa- tion : ( 1 ) A ...
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Bieži izmantoti vārdi un frāzes
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