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 32.
100. lappuse
... master files . 314.430 Availability for public disclosure of data and information in an application or abbreviated application . 314.440 Addresses for applications and ab- breviated applications . 314.445 Guidelines . Subpart H ...
... master files . 314.430 Availability for public disclosure of data and information in an application or abbreviated application . 314.440 Addresses for applications and ab- breviated applications . 314.445 Guidelines . Subpart H ...
102. lappuse
... master files and other applications under this part that are referenced in the application ; and the drug product's proposed indications for use . ( 2 ) A statement whether the submis- sion is an original original submission , a 505 ( b ) ...
... master files and other applications under this part that are referenced in the application ; and the drug product's proposed indications for use . ( 2 ) A statement whether the submis- sion is an original original submission , a 505 ( b ) ...
104. lappuse
... master production record , including a descrip- tion of the equipment , to be used for the manufacture of a commercial lot of the drug product or a comparably de- tailed description of the production process for a representative batch ...
... master production record , including a descrip- tion of the equipment , to be used for the manufacture of a commercial lot of the drug product or a comparably de- tailed description of the production process for a representative batch ...
116. lappuse
... master production record , including a descrip- tion of the equipment , to be used for the manufacture of a commercial lot of the drug product . ( ii ) The information required under §314.50 ( d ) ( 2 ) , ( d ) ( 4 ) ( if an anti ...
... master production record , including a descrip- tion of the equipment , to be used for the manufacture of a commercial lot of the drug product . ( ii ) The information required under §314.50 ( d ) ( 2 ) , ( d ) ( 4 ) ( if an anti ...
120. lappuse
... master cell bank or seed ; and ( F ) Changes which may affect prod- uct sterility assurance , such as changes in product or component steri- lization method ( s ) or an addition , dele- tion , or substitution of steps in an aseptic ...
... master cell bank or seed ; and ( F ) Changes which may affect prod- uct sterility assurance , such as changes in product or component steri- lization method ( s ) or an addition , dele- tion , or substitution of steps in an aseptic ...
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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