FDA's Regulation of the New Drug Versed: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, Second Session, May 5 and 10, 1988, Volume 4U.S. Government Printing Office, 1988 - 599 pages |
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Page 62
... actions taken since the December 1986 meeting . The actions included : ( 1 ) two revisions of the package insert , recommending ... action on the part of the company or FDA . By mid - June , 1987 , there were about 40 cases of serious ...
... actions taken since the December 1986 meeting . The actions included : ( 1 ) two revisions of the package insert , recommending ... action on the part of the company or FDA . By mid - June , 1987 , there were about 40 cases of serious ...
Page 77
... action until you have the defi- nite numbers in front of you . No. 2 , if people are not reporting these numbers to you , why aren't they ? Dr. PECK . It's my understanding that we have no way of knowing the full experience of a drug so ...
... action until you have the defi- nite numbers in front of you . No. 2 , if people are not reporting these numbers to you , why aren't they ? Dr. PECK . It's my understanding that we have no way of knowing the full experience of a drug so ...
Page 78
... action would you take , so we can get this in terms of a real world . Should I pick up the phone and call FDA , should I write a letter , do I doc- ument this clinically ; what is the procedure and what do you folks do to follow up when ...
... action would you take , so we can get this in terms of a real world . Should I pick up the phone and call FDA , should I write a letter , do I doc- ument this clinically ; what is the procedure and what do you folks do to follow up when ...
Page 79
... action or regulatory action or whatever , a system were devised whereby if they report a reaction that could not be used against them in a court of law and this type of thing ? I am very familiar with the aviation sector in the FAA ...
... action or regulatory action or whatever , a system were devised whereby if they report a reaction that could not be used against them in a court of law and this type of thing ? I am very familiar with the aviation sector in the FAA ...
Page 89
... action ? Dr. PECK . I'm going to ask my colleagues to help me answer those two subparts . I would like to point out that , first of all , your point is well taken . We should be aware of and we should be in a position to take into ...
... action ? Dr. PECK . I'm going to ask my colleagues to help me answer those two subparts . I would like to point out that , first of all , your point is well taken . We should be aware of and we should be in a position to take into ...
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Expressions et termes fréquents
adults adverse reactions amnesia Anaesth ANESTHESIOLOGIST anesthetic apnea approved associated Available benzodiazepine bronchoscopy cardiac arrest cardiorespiratory chlordiazepoxide compared CONGRESS THE LIBRARY conscious sedation contraindicated deaths Diazemuls Dormicum dosage dose of midazolam doses of VERSED Drug Administration Dundee effects endoscopists endoscopy evaluate FAICH FDA's fentanyl gastroscopy given Hoffmann-La Roche Hoffmann-La Roche Inc HRG Petition Hypnovel inaudible induction of anesthesia initial dose Injectable VERSED intramuscular intravenous intravenous administration intravenous VERSED JULIEN ketamine labeling letter LIBRARY OF CONGRESS LIGHTFOOT lorazepam marketing MARY Medical meperidine mg/kg mg/ml midazolam and diazepam milligrams minutes monitoring narcotic narcotic premedication Nutley occurred onset outpatient package insert patients receiving PECK physicians physostigmine potent premedication prior procedures received midazolam receiving Versed recommended recovery reported respiratory arrest respiratory depression SCALLY sedative submitted surgery surgical tion titration total dose Valium venous WALTA WARNINGS WEISS
Fréquemment cités
Page 45 - FOOD AND DRUG ADMINISTRATION PUBLIC HEALTH SERVICE DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE OH GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES MAY 5, 1988 FOR RELEASE ONLY UPON DELIVERY Mr.
Page 517 - ... shall appear in the upper left corner of the envelope. (2) The following statement is to appear in the far left third of the envelope in the type and size indicated and in reverse printing, centered in a red rectangle 3% inches wide and 2V4 inches high: IMPORTANT— ELECTRONIC PRODUCT RADIATION WARNING The statement shall be in three lines, all capitals, and centered. "Important" shall be in 36 point Gothic Bold type.
Page 371 - ... hospitalization, or is a congenital anomaly, cancer, or overdose. With respect to results obtained from tests in laboratory animals, a serious adverse drug experience includes any experience suggesting a significant risk for human subjects, including any finding of mutagenicity, teratogenicity, or carcinogenicity. 'Unexpected adverse experience...
Page 517 - USC 371, unless otherwise noted. SOURCE: 40 FR 13996, Mar. 27, 1975, unless otherwise noted. Subpart A — General Provisions § 200.5 Mailing of important information about drugs. Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required...
Page 371 - The sponsor shall notify FDA and all participating investigators in a written IND safety report of any adverse experience associated with use of the drug that is both serious and unexpected. Such notification shall be made as soon as possible and in no event later than 10 working days after the sponsor's initial receipt of the information. Each written notification shall bear prominent identification of its contents, ie, "IND Safety Report.
Page 452 - Severe systemic disturbance or disease from whatever cause, even though it may not be possible to define the degree of disability with finality...
Page 227 - Certification The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
Page 371 - The following definitions of terms apply to this section .Associated with, the use of the drug. There Is a reasonable possibility that the experience may have been caused by the drug. Disability. A substantial disruption of a person's ability to conduct normal life functions. Life-threatening adverse drug experi-ence. Any adverse drug experience...
Page 508 - BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE ON GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES DECEMBER 10, 1987 RELEASE ONLY UPON DELIVERY Food and Drug Administration Rockville MO 20857 Introduction Mr.
Page 518 - Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers. (a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory, warehouse, or establishment in which prescription drugs are manufactured, processed, packed, or held. (b) The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent...