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 82.
8. lappuse
... marketing . 310.501 Patient package inserts for oral con- traceptives . 310.502 Certain drugs accorded new drug sta- tus through rulemaking procedures . 310.503 Requirements regarding certain ra- dioactive drugs . 310.509 Parenteral ...
... marketing . 310.501 Patient package inserts for oral con- traceptives . 310.502 Certain drugs accorded new drug sta- tus through rulemaking procedures . 310.503 Requirements regarding certain ra- dioactive drugs . 310.509 Parenteral ...
20. lappuse
... marketing unless it has been shown to be safe and effective for its intended use ( s ) . After approval , the applicant is required to establish and maintain records and make reports related to clinical experience or other data or in ...
... marketing unless it has been shown to be safe and effective for its intended use ( s ) . After approval , the applicant is required to establish and maintain records and make reports related to clinical experience or other data or in ...
22. lappuse
... marketing 15 - day Alert reports and shall submit followup reports within 15 calendar days of receipt of new infor- mation or as requested by FDA . If addi- tional information is not obtainable , records should be maintained of the un ...
... marketing 15 - day Alert reports and shall submit followup reports within 15 calendar days of receipt of new infor- mation or as requested by FDA . If addi- tional information is not obtainable , records should be maintained of the un ...
24. lappuse
... marketing study ( whether or not conducted under an investigational new drug applica- tion ) unless the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience . ( 2 ) Each person ...
... marketing study ( whether or not conducted under an investigational new drug applica- tion ) unless the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience . ( 2 ) Each person ...
25. lappuse
... Marketing of these products may be continued only under the following conditions : ( 1 ) Digoxin products for oral use , other than tablets : Any person market- ing digoxin products for oral use , other than tablets , shall submit to ...
... Marketing of these products may be continued only under the following conditions : ( 1 ) Digoxin products for oral use , other than tablets : Any person market- ing digoxin products for oral use , other than tablets , shall submit to ...
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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