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.
34. lappuse
... place of business of the manufacturer , packer , or distribu- tor , or the name and place of business of the dispenser of the product . ( ii ) The date , identified as such , of the most recent revision of the patient package insert ...
... place of business of the manufacturer , packer , or distribu- tor , or the name and place of business of the dispenser of the product . ( ii ) The date , identified as such , of the most recent revision of the patient package insert ...
67. lappuse
... 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 official who resides or main- tains a place of business within ...
... 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 official who resides or main- tains a place of business within ...
80. lappuse
... place a pro- posed or ongoing Phase 1 investigation on clinical hold if it finds that : ( i ) Human subjects are or would be exposed to an unreasonable and signifi- cant risk of illness or injury ; ( ii ) The clinical investigators ...
... place a pro- posed or ongoing Phase 1 investigation on clinical hold if it finds that : ( i ) Human subjects are or would be exposed to an unreasonable and signifi- cant risk of illness or injury ; ( ii ) The clinical investigators ...
102. lappuse
... place of business with- in the United States , the application is required to contain the name and ad- dress of , and be countersigned by , an attorney , agent , or other authorized of- ficial who resides or maintains a place of ...
... place of business with- in the United States , the application is required to contain the name and ad- dress of , and be countersigned by , an attorney , agent , or other authorized of- ficial who resides or maintains a place of ...
126. lappuse
... place the words “ Pharmacovigilance and Epidemiology " ; by removing in paragraphs ( c ) ( 2 ) ( ii ) ( b ) , ( d ) ( 2 ) , ( f ) ( 2 ) , and ( f ) ( 3 ) and in the heading for para- graph ( f ) the words " Form FDA - 1639 ” or “ FDA ...
... place the words “ Pharmacovigilance and Epidemiology " ; by removing in paragraphs ( c ) ( 2 ) ( ii ) ( b ) , ( d ) ( 2 ) , ( f ) ( 2 ) , and ( f ) ( 3 ) and in the heading for para- graph ( f ) the words " Form FDA - 1639 ” or “ FDA ...
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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