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, 2001 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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1.–5. rezultāts no 84.
6. 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 ...
7. lappuse
... ( b ) To obtain marketing approval for radioactive biological products for human use , as defined in §600.3 ( ee ) of this chapter , manufacturers must com- ply with the provisions 7 Food and Drug Administration , HHS $ 310.4.
... ( b ) To obtain marketing approval for radioactive biological products for human use , as defined in §600.3 ( ee ) of this chapter , manufacturers must com- ply with the provisions 7 Food and Drug Administration , HHS $ 310.4.
18. 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 ...
19. lappuse
... drug experiences that are the subject of these post- marketing 15 - day Alert reports and shall submit followup reports within 15 calendar days of receipt of new infor- mation or as 19 Food and Drug Administration , HHS §310.305.
... drug experiences that are the subject of these post- marketing 15 - day Alert reports and shall submit followup reports within 15 calendar days of receipt of new infor- mation or as 19 Food and Drug Administration , HHS §310.305.
21. lappuse
... marketing . ( a ) Studies have shown evidence of clinically significant differences in bio- availability in different batches of cer- tain marketed digoxin products for oral use from single manufacturers as well as in batches of these ...
... marketing . ( a ) Studies have shown evidence of clinically significant differences in bio- availability in different batches of cer- tain marketed digoxin products for oral use from single manufacturers as well as in batches of these ...
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Bieži izmantoti vārdi un frāzes
abbre abbreviated application abbreviated new drug acid active ingredients added adverse drug experience agency application or abbreviated aspirin athlete's foot Authority citation revised bacitracin bioavailability bioequivalence cation Center for Drug chapter clinical investigation consult a doctor contains the following Department dient digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing effective date ephedrine Federal Acquisition Regulation FEDERAL REGISTER Food and Drug grams gredients homosalate human ingre introductory text investigational new drug labeling marketing ment milligrams milligrams in 24 misbranded neomycin Office oral dosage orphan drug OTC drug product over-the-counter paragraph patent percent plication polymyxin procedures protocol recognized as safe Redesignated reference listed drug regulations request safe and effective safety salicylate Sodium sponsor submission submitted sulfate sunscreen taining therapeutic tion tive treatment unless directed viated warning
Populāri fragmenti
10. lappuse - ... because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use...
156. lappuse - ... drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under this subsection shall state the findings upon which it is based.
149. lappuse - ... consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
327. lappuse - Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900) VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Parts...
320. lappuse - Board of Governors of the Federal Reserve System (Part 6801) LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101...
321. lappuse - Department of Agriculture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) Chap.
334. lappuse - V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799...
332. lappuse - Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400 — 2499) XXV Corporation for National and Community Service (Parts 2500 — 2599) Title...
66. lappuse - Such information should include identification of the person who conducted each investigation; identification and qualifications of the individuals who evaluated the results and concluded that it is reasonably safe to initiate clinical...
298. lappuse - Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.