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 64.
21. lappuse
... abbreviated new drug ap- plication to establish and maintain records and make reports to FDA of all serious , unexpected adversedrug expe- riences associated with the use of their drug products . Any person subject to the reporting ...
... abbreviated new drug ap- plication to establish and maintain records and make reports to FDA of all serious , unexpected adversedrug expe- riences associated with the use of their drug products . Any person subject to the reporting ...
25. lappuse
... abbreviated new drug application for these products . Any such drug product then on the market which is not the subject of an application submitted for the drug product shall be subject to regulatory procedures under section 505 of the ...
... abbreviated new drug application for these products . Any such drug product then on the market which is not the subject of an application submitted for the drug product shall be subject to regulatory procedures under section 505 of the ...
26. lappuse
... abbreviated new drug application containing adequate data to demonstrate the bioavailability of the reformulated product . Food and Drug Administration approval of the supplement is required before the re- formulated product is marketed ...
... abbreviated new drug application containing adequate data to demonstrate the bioavailability of the reformulated product . Food and Drug Administration approval of the supplement is required before the re- formulated product is marketed ...
30. lappuse
... Abbreviated new drug applications shall be 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 ...
... Abbreviated new drug applications shall be 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 ...
44. lappuse
... abbreviated new drug applica- tion , such product is also misbranded under section 502 of the act . ( c ) Clinical investigations designed to obtain evidence that any drug prod- uct labeled , represented , or promoted for OTC use as a ...
... abbreviated new drug applica- tion , such product is also misbranded under section 502 of the act . ( c ) Clinical investigations designed to obtain evidence that any drug prod- uct labeled , represented , or promoted for OTC use as a ...
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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