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.
37. lappuse
... means a terminally sterilized aqueous drug product packaged in a single - dose container with a capacity of 100 milliliters or more and intended to be administered or used intra- venously in a human . ( c ) Until the results of ...
... means a terminally sterilized aqueous drug product packaged in a single - dose container with a capacity of 100 milliliters or more and intended to be administered or used intra- venously in a human . ( c ) Until the results of ...
41. lappuse
... means a method of packaging a prod- uct into a nonreusable container de- signed to hold a single dosage unit in- tended for administration directly from that container , irrespective of whether the recommended dose is one or more than ...
... means a method of packaging a prod- uct into a nonreusable container de- signed to hold a single dosage unit in- tended for administration directly from that container , irrespective of whether the recommended dose is one or more than ...
46. lappuse
... means other than cleansing and irrigating , or by serving as a protectant . Allantoin , car- bamide peroxide in ... mean- ing of section 201 ( p ) of the Federal Food , Drug , and Cosmetic Act , for which an approved new drug applica ...
... means other than cleansing and irrigating , or by serving as a protectant . Allantoin , car- bamide peroxide in ... mean- ing of section 201 ( p ) of the Federal Food , Drug , and Cosmetic Act , for which an approved new drug applica ...
63. lappuse
... means the Federal Food , Drug , and Cosmetic Act ( secs . 201-902 , 52 Stat . 1040 et seq . , as amended ( 21 U.S.C. 301-392 ) ) . Clinical investigation means any ex- periment in which a drug is adminis- tered or dispensed to , or used ...
... means the Federal Food , Drug , and Cosmetic Act ( secs . 201-902 , 52 Stat . 1040 et seq . , as amended ( 21 U.S.C. 301-392 ) ) . Clinical investigation means any ex- periment in which a drug is adminis- tered or dispensed to , or used ...
64. lappuse
... means . A waiver request is re- quired to contain at least one of the following : ( 1 ) An explanation why the sponsor's compliance with the requirement is un- necessary or cannot be achieved ; ( 2 ) A description of an alternative ...
... means . A waiver request is re- quired to contain at least one of the following : ( 1 ) An explanation why the sponsor's compliance with the requirement is un- necessary or cannot be achieved ; ( 2 ) A description of an alternative ...
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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