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.
107. lappuse
... methods . ( i ) Four representative samples of the following , each sample in sufficient quantity to permit FDA to perform three times each test described in the application to determine whether the drug substance and the drug product ...
... methods . ( i ) Four representative samples of the following , each sample in sufficient quantity to permit FDA to perform three times each test described in the application to determine whether the drug substance and the drug product ...
109. lappuse
... Method of use patent . ( A ) If infor- mation that is submitted under section 505 ( b ) or ( c ) of the act and §314.53 is for a method of use patent , and the label- ing for the drug product for which the applicant is seeking approval ...
... Method of use patent . ( A ) If infor- mation that is submitted under section 505 ( b ) or ( c ) of the act and §314.53 is for a method of use patent , and the label- ing for the drug product for which the applicant is seeking approval ...
114. lappuse
... method of use , the applicant shall submit infor- mation only on those patents that claim indications or other conditions of use of a pending or approved applica- tion . ( c ) Reporting requirements- ( 1 ) General requirements . An ...
... method of use , the applicant shall submit infor- mation only on those patents that claim indications or other conditions of use of a pending or approved applica- tion . ( c ) Reporting requirements- ( 1 ) General requirements . An ...
118. lappuse
... method ; ( iv ) To delete a specification or regu- latory analytical method ; ( v ) To change the method of manu- facture of the drug product , including changing or relaxing an in - process con- trol ; ( vi ) To use a different ...
... method ; ( iv ) To delete a specification or regu- latory analytical method ; ( v ) To change the method of manu- facture of the drug product , including changing or relaxing an in - process con- trol ; ( vi ) To use a different ...
135. lappuse
... Method of use patent . ( A ) If pat- ent information is submitted under section 505 ( b ) or ( c ) of the act and §314.53 for a patent claiming a method of using the listed drug , and the label- ing for the drug product for which the ...
... Method of use patent . ( A ) If pat- ent information is submitted under section 505 ( b ) or ( c ) of the act and §314.53 for a patent claiming a method of using the listed drug , and the label- ing for the drug product for which 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