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.
8. lappuse
... Records and Reports 310.303 Continuation of long - term studies , records , and reports on certain drugs for which new drug applications have been approved . 310.305 Records and reports concerning ad- verse drug experiences on marketed ...
... Records and Reports 310.303 Continuation of long - term studies , records , and reports on certain drugs for which new drug applications have been approved . 310.305 Records and reports concerning ad- verse drug experiences on marketed ...
12. lappuse
... records of all shipments for this purpose for a period of 2 years after shipment and will make them available to the Food and Drug Admin- istration on request . ( b ) When the requested new drug sub- stance is intended for ...
... records of all shipments for this purpose for a period of 2 years after shipment and will make them available to the Food and Drug Admin- istration on request . ( b ) When the requested new drug sub- stance is intended for ...
20. lappuse
... Records and Reports §310.303 Continuation of of long - term studies , records , and reports on cer- tain drugs for which new drug ap- plications have been approved . ( a ) A new drug may not be approved for marketing unless it has been ...
... Records and Reports §310.303 Continuation of of long - term studies , records , and reports on cer- tain drugs for which new drug ap- plications have been approved . ( a ) A new drug may not be approved for marketing unless it has been ...
21. lappuse
... records , and reports will be published in § 310.304 . [ 39 FR 11680 , Mar. 29 , 1974 , as amended at 41 FR 4714 , Jan. 25 , 1976 ; 42 FR 15674 , Mar. 22 , 1977 ] § 310.305 Records and reports concern- ing adverse drug experiences on ...
... records , and reports will be published in § 310.304 . [ 39 FR 11680 , Mar. 29 , 1974 , as amended at 41 FR 4714 , Jan. 25 , 1976 ; 42 FR 15674 , Mar. 22 , 1977 ] § 310.305 Records and reports concern- ing adverse drug experiences on ...
22. lappuse
... records should be maintained of the un- successful steps taken to seek addi- tional information . Postmarketing 15 ... record of this action which shall include : ( i ) A copy of each adverse drug expe- rience report ; ( ii ) The date ...
... records should be maintained of the un- successful steps taken to seek addi- tional information . Postmarketing 15 ... record of this action which shall include : ( i ) A copy of each adverse drug expe- rience report ; ( ii ) The date ...
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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