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.
11. lappuse
... specific product by writing to the Food and Drug Administration at the address shown in paragraph ( e ) of this section . ( c ) Manufacturers and distributors of drugs should review their products as drug efficacy notices are published ...
... specific product by writing to the Food and Drug Administration at the address shown in paragraph ( e ) of this section . ( c ) Manufacturers and distributors of drugs should review their products as drug efficacy notices are published ...
24. lappuse
... Specific New Drugs or Devices §310.500 Digoxin products for oral use ; conditions for marketing . ( a ) Studies have shown evidence of clinically significant differences in bio- availability in different batches of cer- tain marketed ...
... Specific New Drugs or Devices §310.500 Digoxin products for oral use ; conditions for marketing . ( a ) Studies have shown evidence of clinically significant differences in bio- availability in different batches of cer- tain marketed ...
67. lappuse
... specific obligations trans- ferred - may be submitted . ( ix ) The signature of the sponsor or the sponsor's authorized representa- tive . If the person signing the applica- tion does not reside or have a place of business within the ...
... specific obligations trans- ferred - may be submitted . ( ix ) The signature of the sponsor or the sponsor's authorized representa- tive . If the person signing the applica- tion does not reside or have a place of business within the ...
72. lappuse
... specific technical information in the IND or in a concurrently submitted information amendment to the IND that the spon- sor relies on to support any clinically significant change in in the new or amended protocol . If the reference is ...
... specific technical information in the IND or in a concurrently submitted information amendment to the IND that the spon- sor relies on to support any clinically significant change in in the new or amended protocol . If the reference is ...
95. lappuse
... specific drug product used in the clinical study , if available ; and ( 5 ) If the study is intended to support the effectiveness of a drug product , in- formation showing that the study is adequate and well controlled under §314.126 ...
... specific drug product used in the clinical study , if available ; and ( 5 ) If the study is intended to support the effectiveness of a drug product , in- formation showing that the study is adequate and well controlled under §314.126 ...
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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