The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 2002 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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abbreviated application abbreviated new drug acid active ingredients added adverse drug experience agency amended application or abbreviated aspirin Authority citation revised bacitracin bioavailability bioequivalence cation Center for Drug chapter chloride clinical investigation consult a doctor Cosmetic Act dient digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing ephedrine Federal Acquisition Regulation Federal Food FEDERAL REGISTER Food and Drug grams gredients hydrochloride identified ingre introduction into interstate investigational new drug labeling manufacturer marketing ment milligrams milligrams in 24 misbranded Office OMB number oral dosage orphan drug OTC drug product package paragraph patent percent plication preparation procedures protocol recognized as safe regulations request safe and effective safety salicylate Salicylic acid section 502 Sodium sponsor submission submitted Subpart sulfate sunscreen taining tion treatment unless directed
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6. lappuse - Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling.
335. lappuse - Office of the Secretary of Defense (Parts 1399) V Department of the Army (Parts 400699) VI Department of the Navy (Parts 700799) VII Department of the Air Force (Parts 8001099) SUBTITLE B OTHER REGULATIONS RELATING TO NATIONAL DEFENSE XII Defense Logistics Agency (Parts 12001299) XVI Selective Service System (Parts 16001699) XVIII National Counterintelligence Center (Parts 18001899) XIX Central Intelligence Agency (Parts 19001999) XX Information Security Oversight Office,...
160. 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.
153. 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.
340. lappuse - Management (Parts 1700 1799) 18 National Aeronautics and Space Administration (Parts 1800 1899) 19 Broadcasting Board of Governors (Parts 19001999) 20 Nuclear Regulatory Commission (Parts 20002099) 21 Office of Personnel Management, Federal Employees...
332. lappuse - Office of the Assistant Secretary for Housing Federal Housing Commissioner, Department of Housing and Urban Development (Section 8 Housing Assistance Programs, Section 202 Direct Loan Program, Section 202 Supportive Housing for the Elderly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800899...
344. lappuse - Corporation for National and Community Service Cost Accounting Standards Board Council on Environmental Quality Court Services and Offender Supervision Agency for the District of Columbia Customs and Border Protection Bureau Defense Contract Audit Agency Defense Department...
82. lappuse - The investigator is required to furnish his reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained by various investigators. The sponsor is required to present progress reports to the Food and Drug Administration at appropriate intervals not exceeding 1 year.
316. lappuse - DENTURE RELINERS, PADS, AND CUSHIONS. Warning For temporary use only. Long-term use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Until a Dentist Can Be Seen. DENTURE REPAIR KITS. Warning For emergency repairs only. Long-term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This kit for emergency use only. See Dentist Without Delay.
319. lappuse - 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.