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.
108. lappuse
... reference drugs or pla- cebo . This requirement may be waived by FDA for specific studies if the case report forms ... reference . A reference to information submitted previously is required to identify the file by name , reference ...
... reference drugs or pla- cebo . This requirement may be waived by FDA for specific studies if the case report forms ... reference . A reference to information submitted previously is required to identify the file by name , reference ...
117. lappuse
... reference listed drug is that : ( 1 ) The extent to which its active in- gredient ( s ) is absorbed or otherwise made available to the site of action is less than that of the reference listed drug ; or ( 2 ) The rate at which its active ...
... reference listed drug is that : ( 1 ) The extent to which its active in- gredient ( s ) is absorbed or otherwise made available to the site of action is less than that of the reference listed drug ; or ( 2 ) The rate at which its active ...
130. lappuse
... reference listed drug shall submit a petition in accordance with §10.20 of this chapter and in the format specified in §10.30 of this chapter . The petition shall contain the information specified in §10.30 of this chapter and any addi ...
... reference listed drug shall submit a petition in accordance with §10.20 of this chapter and in the format specified in §10.30 of this chapter . The petition shall contain the information specified in §10.30 of this chapter and any addi ...
131. lappuse
... reference listed drug ; or ( ii ) For a petition that seeks to change an active ingredient , the drug product that is the subject of the peti- tion is not a combination drug ; or ( iii ) For a combination drug product that is the ...
... reference listed drug ; or ( ii ) For a petition that seeks to change an active ingredient , the drug product that is the subject of the peti- tion is not a combination drug ; or ( iii ) For a combination drug product that is the ...
132. lappuse
... reference standard for conducting bioequivalence testing . The application shall contain : ( i ) The name of the reference listed drug , including its dosage form and strength . For an abbreviated new drug application based on an ...
... reference standard for conducting bioequivalence testing . The application shall contain : ( i ) The name of the reference listed drug , including its dosage form and strength . For an abbreviated new drug application based on an ...
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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