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.
106. lappuse
... specific subgroups . Ef- fectiveness data from other subgroups of the population of patients treated , when appropriate , such as patients with renal failure or patients with dif- ferent levels of severity of the disease , also shall be ...
... specific subgroups . Ef- fectiveness data from other subgroups of the population of patients treated , when appropriate , such as patients with renal failure or patients with dif- ferent levels of severity of the disease , also shall be ...
136. lappuse
... specific date . Once an amendment or letter for the change has been submitted , the ap- plication will no longer be considered to be one containing a certification under paragraph ( a ) ( 12 ) ( i ) ( A ) ( 4 ) of this section . If a ...
... specific date . Once an amendment or letter for the change has been submitted , the ap- plication will no longer be considered to be one containing a certification under paragraph ( a ) ( 12 ) ( i ) ( A ) ( 4 ) of this section . If a ...
149. lappuse
... specific additional information or material is submitted or specific conditions ( for example , cer- tain changes in labeling ) are agreed to by the applicant . The approvable letter will describe the information or mate- rial FDA ...
... specific additional information or material is submitted or specific conditions ( for example , cer- tain changes in labeling ) are agreed to by the applicant . The approvable letter will describe the information or mate- rial FDA ...
155. lappuse
... specific clinical investiga- tion , either prior to the investigation or in the evaluation of a completed study . A petition for a waiver is re- quired to set forth clearly and con- cisely the specific criteria from which waiver is ...
... specific clinical investiga- tion , either prior to the investigation or in the evaluation of a completed study . A petition for a waiver is re- quired to set forth clearly and con- cisely the specific criteria from which waiver is ...
163. lappuse
... specific ( that is , either refer- ring to specific requirements in the statute and regulations with which there is a lack of compliance , or pro- viding a detailed description and anal- ysis of the specific facts resulting in the ...
... specific ( that is , either refer- ring to specific requirements in the statute and regulations with which there is a lack of compliance , or pro- viding a detailed description and anal- ysis of the specific facts resulting in 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