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 56.
9. lappuse
... sponsor means the per- son or agency who assumes responsibil- ity for an investigation of a new drug , including responsibility for compliance with applicable provisions of the act and regulations . The " sponsor ” may be an individual ...
... sponsor means the per- son or agency who assumes responsibil- ity for an investigation of a new drug , including responsibility for compliance with applicable provisions of the act and regulations . The " sponsor ” may be an individual ...
37. lappuse
... sponsor of the investigation of such drug submits on or before August 25 , 1975 to the Food and Drug Administration , Bureau of Drugs , HFD - 150 , 5600 Fishers Lane , Rockville , MD 20857 , the following in- formation : ( 1 ) The ...
... sponsor of the investigation of such drug submits on or before August 25 , 1975 to the Food and Drug Administration , Bureau of Drugs , HFD - 150 , 5600 Fishers Lane , Rockville , MD 20857 , the following in- formation : ( 1 ) The ...
61. lappuse
... Sponsors and Investigators 312.50 General responsibilities of sponsors . 312.52 Transfer of obligations to a contract ... sponsor's records and reports . 312.59 Disposition of unused supply of inves- tigational drug . 312.60 General ...
... Sponsors and Investigators 312.50 General responsibilities of sponsors . 312.52 Transfer of obligations to a contract ... sponsor's records and reports . 312.59 Disposition of unused supply of inves- tigational drug . 312.60 General ...
63. lappuse
... sponsor , one or more of the obligations of a sponsor , e.g. , design of a protocol , selection or monitoring of investigations , evalua- tion of reports , and preparation of ma- terials to be submitted to the Food and Drug ...
... sponsor , one or more of the obligations of a sponsor , e.g. , design of a protocol , selection or monitoring of investigations , evalua- tion of reports , and preparation of ma- terials to be submitted to the Food and Drug ...
64. lappuse
... sponsor or investigator , or any person acting on behalf of a sponsor or investigator , shall not represent in a promotional context that an investiga- tional new drug is safe or effective for the purposes for which it is under in ...
... sponsor or investigator , or any person acting on behalf of a sponsor or investigator , shall not represent in a promotional context that an investiga- tional new drug is safe or effective for the purposes for which it is under in ...
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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