Postmarketing surveillance of prescription drugs.DIANE Publishing |
Common terms and phrases
95 percent sure added incidence ADRs adverse drug reactions adverse effects adverse reactions application was approved approved drug associated background incidence basis Beta-Blocker case-control studies Center for Drug cimetidine cohort studies Commission on Prescription control group Controlled clinical trials detect develop device disease Drug Administration drug application drug approval process drug effects drug evaluation Drug Safety drug users drug's efficacy and safety FDA’s fects Food and Drug frequency heart attacks Hospital identified imminent hazard incidence of adverse issue long-term manufacturers marketing surveillance Medicaid ment methods Monitoring for Drug National Center Number of patients options oral contraceptives phase 111 testing phase III testing physicians postmarketing period postmarketing studies postmarketing surveillance practolol premarketing approval process premarketing tests prescribed prescription drugs propanolol proval registries regulatory release risk Secretary sponsor Streptokinase substantial evidence sure of observing Technology Assessment therapeutic tients timolol tion toxicity voluntary reporting well-controlled
Popular passages
Page 57 - Secretary for filing final briefs. (d) If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested...
Page 57 - As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved...
Page 50 - 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,...
Page 60 - ... (I) the categories of sources of records in the system; (5) maintain all records which are used by the agency in making any determination about any individual with such accuracy, relevance, timeliness, and completeness as is reasonably necessary to assure fairness to the individual in the determination...
Page 58 - That on the basic of new information before him evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for the manufacture, processing, and packIng of such...
Page 57 - ... (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity...
Page 57 - Administration with respect to such drug, there is lack of substantial 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, or suggested...
Page 57 - Is unsafe for use under the conditions of use upon the basis of which the application was approved...
Page 58 - ... 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.
Page 57 - Information before him with respect to such drug, there is a lack of substantial evidence 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 proposed labeling thereof; ... he shall issue an order refusing to approve the application.