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.
22. lappuse
... submitted under separate cover . ( 3 ) Submission of reports . To avoid un- necessary duplication in the submis- sion of , and followup to , reports re- quired in this section , a packer's or dis- tributor's obligations may be met by ...
... submitted under separate cover . ( 3 ) Submission of reports . To avoid un- necessary duplication in the submis- sion of , and followup to , reports re- quired in this section , a packer's or dis- tributor's obligations may be met by ...
23. lappuse
... submitted by a manufacturer , packer , or distributor under this sec- tion ( and any release by FDA of that report or information ) does not nec- essarily reflect a conclusion by the manufacturer , packer , or distributor , or by FDA ...
... submitted by a manufacturer , packer , or distributor under this sec- tion ( and any release by FDA of that report or information ) does not nec- essarily reflect a conclusion by the manufacturer , packer , or distributor , or by FDA ...
24. lappuse
... submitted to the manufacturer . ( iv ) Name and address of the manufacturer . ( 5 ) Each report submitted to FDA under this section shall bear prominent identifica- tion as to its contents , i.e. , " 15 - day Alert re- port " or " 15 ...
... submitted to the manufacturer . ( iv ) Name and address of the manufacturer . ( 5 ) Each report submitted to FDA under this section shall bear prominent identifica- tion as to its contents , i.e. , " 15 - day Alert re- port " or " 15 ...
30. lappuse
... submitted to the Food and Drug Administration , Center for Drug Evaluation and Research , Office of Ge- neric Drugs , 5600 Fishers Lane , Rock- ville , MD 20857 . ( g ) All samples of digoxin tablets re- quired by paragraph ( a ) ( 3 ) ...
... submitted to the Food and Drug Administration , Center for Drug Evaluation and Research , Office of Ge- neric Drugs , 5600 Fishers Lane , Rock- ville , MD 20857 . ( g ) All samples of digoxin tablets re- quired by paragraph ( a ) ( 3 ) ...
36. lappuse
... submitted prior to March 3 , 1972 , or for which biologic an applica- tion for product license or " Investiga- tional New Drug Application " was sub- mitted prior to March 3 , 1972 , is termi- nated on August 20 , 1976 , unless an ap ...
... submitted prior to March 3 , 1972 , or for which biologic an applica- tion for product license or " Investiga- tional New Drug Application " was sub- mitted prior to March 3 , 1972 , is termi- nated on August 20 , 1976 , unless an ap ...
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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