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
... person whose name appears on the label of a marketed 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 ...
... person whose name appears on the label of a marketed 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 ...
25. lappuse
... person market- ing digoxin products for oral use , other than tablets , shall submit to the Food and Drug Administration on or before February 21 , 1974 , an abbreviated new drug application for these products . Any such drug product ...
... person market- ing digoxin products for oral use , other than tablets , shall submit to the Food and Drug Administration on or before February 21 , 1974 , an abbreviated new drug application for these products . Any such drug product ...
63. lappuse
... person that assumes , as an independent contractor with the sponsor , one or more of the obligations of a sponsor , e.g. , design of a protocol , selection or monitoring of investigations , evalua- tion of reports , and preparation of ...
... person that assumes , as an independent contractor with the sponsor , one or more of the obligations of a sponsor , e.g. , design of a protocol , selection or monitoring of investigations , evalua- tion of reports , and preparation of ...
66. lappuse
... person responsible for monitoring the conduct and progress of the clinical investiga- tions . ( vii ) The name ( s ) and title ( s ) of the person ( s ) responsible under §312.32 for review and evaluation of information relevant to the ...
... person responsible for monitoring the conduct and progress of the clinical investiga- tions . ( vii ) The name ( s ) and title ( s ) of the person ( s ) responsible under §312.32 for review and evaluation of information relevant to the ...
67. lappuse
... person signing the applica- tion does not reside or have a place of business within the United States , the IND is required to contain the name and address of , and be countersigned by , an attorney , agent , or other au- thorized ...
... person signing the applica- tion does not reside or have a place of business within the United States , the IND is required to contain the name and address of , and be countersigned by , an attorney , agent , or other au- thorized ...
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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