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. |
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1.–5. rezultāts no 100.
23. lappuse
... amended at 52 FR 37936 , Oct. 13 , 1987 ; 55 FR 11578 , Mar. 29 , 1990 ; 57 FR 17980 , Apr. 28 , 1992 ; 62 FR 34167 , June 25 , 1997 ; 62 FR 52249 , Oct. 7 , 1997 ] EFFECTIVE DATE NOTE : At 62 FR 52249 , Oct. 7 , 1997 , § 310.305 was ...
... amended at 52 FR 37936 , Oct. 13 , 1987 ; 55 FR 11578 , Mar. 29 , 1990 ; 57 FR 17980 , Apr. 28 , 1992 ; 62 FR 34167 , June 25 , 1997 ; 62 FR 52249 , Oct. 7 , 1997 ] EFFECTIVE DATE NOTE : At 62 FR 52249 , Oct. 7 , 1997 , § 310.305 was ...
63. lappuse
... amended at 61 FR 51529 , Oct. 2 , 1996 ] § 312.3 Definitions and interpretations . ( a ) The definitions and interpreta- tions of terms contained in section 201 of the Act apply to those terms when used in this part : ( b ) The ...
... amended at 61 FR 51529 , Oct. 2 , 1996 ] § 312.3 Definitions and interpretations . ( a ) The definitions and interpreta- tions of terms contained in section 201 of the Act apply to those terms when used in this part : ( b ) The ...
64. lappuse
... amendment submitted under §312.31 . Authorization for charging goes into effect automati- cally 30 days after receipt by ... amended at 52 FR 19476 , May 22 , 1987 ] § 312.10 Waivers . ( a ) A sponsor may request FDA to waive applicable ...
... amendment submitted under §312.31 . Authorization for charging goes into effect automati- cally 30 days after receipt by ... amended at 52 FR 19476 , May 22 , 1987 ] § 312.10 Waivers . ( a ) A sponsor may request FDA to waive applicable ...
65. lappuse
... amended at 52 FR 23031 , June 17 , 1987 ] Subpart B - Investigational New Drug Application ( IND ) § 312.20 Requirement for an IND . ( a ) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation ...
... amended at 52 FR 23031 , June 17 , 1987 ] Subpart B - Investigational New Drug Application ( IND ) § 312.20 Requirement for an IND . ( a ) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation ...
71. lappuse
... amended at 52 FR 23031 , June 17 , 1987 ; 53 FR 1918 , Jan. 25 , 1988 ; 61 FR 51529 , Oct. 2 , 1996 ; 62 FR 40599 , July 29 , 1997 ] § 312.30 Protocol amendments . Once an IND is in effect , a sponsor shall amend it as needed to ensure ...
... amended at 52 FR 23031 , June 17 , 1987 ; 53 FR 1918 , Jan. 25 , 1988 ; 61 FR 51529 , Oct. 2 , 1996 ; 62 FR 40599 , July 29 , 1997 ] § 312.30 Protocol amendments . Once an IND is in effect , a sponsor shall amend it as needed to ensure ...
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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