The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1992 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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1.5. rezultāts no 73.
6. lappuse
... term studies , records , and reports on certain drugs for which new drug applications have been approved . 310.304 Drugs that are subjects of ap- proved new drug applications and that require special studies , records , and re- ports ...
... term studies , records , and reports on certain drugs for which new drug applications have been approved . 310.304 Drugs that are subjects of ap- proved new drug applications and that require special studies , records , and re- ports ...
7. lappuse
... term sponsor means the person or agency who assumes respon- sibility for an investigation of a new drug , including responsibility for com- pliance with applicable provisions of the act and regulations . The " sponsor " may be an ...
... term sponsor means the person or agency who assumes respon- sibility for an investigation of a new drug , including responsibility for com- pliance with applicable provisions of the act and regulations . The " sponsor " may be an ...
8. lappuse
... terms and conditions as set forth in such license and such portions of the establishment license relating to such product , which include data and infor- mation required under Part 314 of this chapter for a new drug application . Any ...
... terms and conditions as set forth in such license and such portions of the establishment license relating to such product , which include data and infor- mation required under Part 314 of this chapter for a new drug application . Any ...
10. lappuse
... terms of § 81.25 of this chapter . The use of FD & C Red No. 4 or mixtures containing it in the manu- facture of ingested drugs ( except for limited use as provided in § 81.25 of this chapter ) will result in adultera- tion and may ...
... terms of § 81.25 of this chapter . The use of FD & C Red No. 4 or mixtures containing it in the manu- facture of ingested drugs ( except for limited use as provided in § 81.25 of this chapter ) will result in adultera- tion and may ...
21. lappuse
... term stud- ies , records , and reports on certain drugs for which new drug applications have been approved . ( a ) A new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use ( s ) ...
... term stud- ies , records , and reports on certain drugs for which new drug applications have been approved . ( a ) A new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use ( s ) ...
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300 milligrams accurately weighed acid active ingredients addition to complying agar diffusion assay amdinocillin amended ampicillin azlocillin batch for potency Calculate cefotiam cefpiramide ceftazidime ceftriaxone cefuroxime chapter chromatograph clavulanic acid crystallinity cyclacillin described in paragraph dicloxacillin dilute to volume Dissolve distilled water dosage forms drug product Food and Drug Further dilute gentamicin hetacillin hydrochloride immediate containers injection labeled in accordance less than 90 loss on drying lution master standard means a specific methods of assay-(1 micrograms milligrams milliliter milliliter estimated mobile phase monohydrate nafcillin neomycin neomycin sulfate number of milligrams oxacillin peak penicillin ples polymyxin potassium phosphate preparing the sample Proceed as directed products containing pyrogens reagent represented to contain request shall contain Requests for certification Requirements for certification Results of tests sample solution sodium solu standard solution Standards of identity stock solution Subpart tablets tests and assays Tests and methods tests except sterility ticarcillin tion volumetric flask
Populāri fragmenti
94. lappuse - The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
135. lappuse - As used in this subsection and subsection (e), the term "substantial evidence" means evidence 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,...
95. lappuse - The refusal of the patient to participate in a study must never interfere with the physician-patient relationship. 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2). 6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research...
125. lappuse - Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...
125. lappuse - ... drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the...
286. lappuse - ... of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use; or in law enforcement; or in research not involving clinical use; or in chemical analysis or physical testing, provided they are to be used only for such instruction, law enforcement, research, analysis, or testing, and provided further that their labels bear the statement "Not for drug use.
95. lappuse - In any medical study, every patient including those of a control group, if any should be assured of the best proven diagnostic and therapeutic method.
234. lappuse - If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.
94. lappuse - Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity...
134. lappuse - A person who requests a hearing may not rely upon allegations or denials but is required to set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing with respect to a particular drug product specified in the request for hearing. (i) Where a specific notice of opportunity for hearing (as defined in paragraph (b)(l) of this section) is used, the Commissioner will enter summary judgment against a person who requests a hearing, making findings and...