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 74.
8. lappuse
... 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 pre- scription drugs for human use without approved ...
... 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 pre- scription drugs for human use without approved ...
9. lappuse
... term person includes individ- uals , partnerships , corporations , and associations . ( f ) The definitions and interpreta- tions of terms contained in section 201 of the act shall be applicable to such terms when used in the ...
... term person includes individ- uals , partnerships , corporations , and associations . ( f ) The definitions and interpreta- tions of terms contained in section 201 of the act shall be applicable to such terms when used in the ...
10. lappuse
... terms and conditions as set forth in such license and such portions of the establishment license relating to such product , which include data and information required under part 314 of this chapter for a new drug application . Any such ...
... terms and conditions as set forth in such license and such portions of the establishment license relating to such product , which include data and information required under part 314 of this chapter for a new drug application . Any such ...
20. lappuse
... 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 shown to be safe and effective for its intended use ( s ) ...
... 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 shown to be safe and effective for its intended use ( s ) ...
21. lappuse
... terms apply to this section : - Adverse drug experience . Any adverse event associated with the use of a drug in humans , whether or not considered drug related , including the following : An adverse event occurring in the course of the ...
... terms apply to this section : - Adverse drug experience . Any adverse event associated with the use of a drug in humans , whether or not considered drug related , including the following : An adverse event occurring in the course of the ...
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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