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.
94. lappuse
... request from the person that seeks to export the drug . A request must provide adequate information about the drug to satisfy FDA that the drug is appropriate for the proposed in- vestigational use in humans , that the drug will be used ...
... request from the person that seeks to export the drug . A request must provide adequate information about the drug to satisfy FDA that the drug is appropriate for the proposed in- vestigational use in humans , that the drug will be used ...
107. lappuse
... requested during the conduct of FDA's review of the ap- plication . If If such unforeseen cir- cumstances do occur , any request for deleted tabulations will be made by the director of the FDA division respon- sible for reviewing the ...
... requested during the conduct of FDA's review of the ap- plication . If If such unforeseen cir- cumstances do occur , any request for deleted tabulations will be made by the director of the FDA division respon- sible for reviewing the ...
115. lappuse
... request for copies of the file shall be sent in writing to the Freedom of Information Staff ( HFI - 35 ) , Food and Drug Administration , rm . 12A - 16 , 5600 Fishers Lane , Rockville , MD 20857 . ( f ) Correction of patent information ...
... request for copies of the file shall be sent in writing to the Freedom of Information Staff ( HFI - 35 ) , Food and Drug Administration , rm . 12A - 16 , 5600 Fishers Lane , Rockville , MD 20857 . ( f ) Correction of patent information ...
130. lappuse
... request- ing the change . A person seeking per- mission to request such a change from a 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 ...
... request- ing the change . A person seeking per- mission to request such a change from a 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 ...
150. lappuse
... request to the Associate Director for Policy ( HFD 5 ) , Center for Drug Evaluation and Re- search , Food and Drug ... request for such an extension . FDA will consider the applicant's fail- ure to respond further within the ex- tended ...
... request to the Associate Director for Policy ( HFD 5 ) , Center for Drug Evaluation and Re- search , Food and Drug ... request for such an extension . FDA will consider the applicant's fail- ure to respond further within the ex- tended ...
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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