Unexpected Adverse Drug Reaction definition

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information.
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Unexpected Adverse Drug Reaction. ("UADR") means an ADR, the nature or severity of which is not consistent with the applicable product information
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Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product).
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Examples of Unexpected Adverse Drug Reaction in a sentence

  • An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature or severity of which is not consistent with the applicable product information.

  • Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with applicable product reference safety information (Section 6.5 of the Investigator Brochure).

  • Unexpected Adverse Drug Reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or package insert/summary of product characteristics for an approved product).

  • It was shown that the proteolytic activity in all yogurt Table 2.

  • Unexpected Adverse Drug Reaction (abbreviated as UADR) - shall mean such adverse drug reaction the nature, severity or consequences of which are not consistent with the information laid down in the summary of the product characteristics for an authorised medicinal product or which are not consistent with available information, e.g. the investigator's brochure for an investigational medicinal product without marketing authorisation (Section 3, paragraph 4 (b) of the Act).

  • Serious and Unexpected Adverse Drug Reaction (SUADR) SUADRs are SADR that are unexpected, where severity of which is not consistent with the applicable product information of each component of the paste and suspension.All SUADRs will have expedited reporting to regulatory agencies following ICH-GCP and local regulatory requirements.

  • An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature or severity of which is not consistent with the current Investigator’s Brochure.

  • Serious Adverse Event is an event characterized by any of the following: • Death • Life-threatening condition • Hospitalization (initial/prolonged) • Disability • Congenital anomaly • Requires intervention to prevent permanent impairment or damage Unexpected Adverse Drug Reaction (ADR) is an adverse reaction the nature or severity of which is not consistent with the investigator’s brochure.

  • Unexpected Adverse Drug Reaction: an unexpected Adverse Drug Reaction is “an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product)”.

  • An Unexpected Adverse Drug Reaction is any adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure).


More Definitions of Unexpected Adverse Drug Reaction

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable investigational product information.
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Unexpected Adverse Drug Reaction. An Adverse Drug Reaction where the nature and/or severity of the reaction is not consistent with the term or description used in the IB . Unlisted Adverse Drug Reaction: An ADR, the nature, severity, specificity or outcome of which is not consistent with the information included In the applicable CCSI or local equivalent reference label. · Valid Case: A case that includes each of the following minimum criteria: • An identifiable patient; • The name of the suspect Medicinal Product(s) or Clinical Study if considered related to a Clinical Study procedure/design; • An identifiable reporting source; • An event or outcome.
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Unexpected Adverse Drug Reaction. An Adverse Drug Reaction where the nature and/or severity of the reaction is not consistent with the term or description used in the IB. Unlisted Adverse Drug Reaction: An ADR, the nature, severity, specificity or outcome of which is not consistent with the information included in the applicable CCSI or local equivalent reference label.
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Unexpected Adverse Drug Reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with domestic labeling, marketing authorization or the SmPC.
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Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information; CHAPTER II: APPLICATION, ASSESSMENT, INSPECTION AND REPORTING IN CLINICAL TRIALS
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Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information;
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Related to Unexpected Adverse Drug Reaction

  • Adverse Drug Reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Adverse Event means any untoward medical occurrence in a human clinical trial subject or in a patient who is administered a Licensed Product, whether or not having a causal relationship with such Licensed Product, including, without limitation, any unfavorable and unintended sign (including, without limitation, abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Material Adverse Event means an occurrence having a consequence that either (a) is materially adverse as to the business, properties, prospects or financial condition of the Company taken as a whole or (b) is reasonably foreseeable, has a reasonable likelihood of occurring and, if it were to occur, would materially adversely affect the business, properties, prospects or financial condition of the Company taken as a whole.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Adverse system impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Adverse decision means a utilization review determination by the utilization review entity that a

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • Data Subjects means all individuals whose Personal Information we receive in the course of our banking relationship with you, including your direct and indirect beneficial owners, directors, officers and authorized persons.

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Cancer drug means a prescription drug used to treat:

  • Inherited Metabolic Disorder means a disease caused by an inherited abnormality of body chemistry that meets all of the following requirements:

  • Regulatory Disruption Any event that Dealer, based on the advice of counsel, determines makes it reasonably necessary or appropriate with regard to any legal, regulatory or self-regulatory requirements or related policies and procedures that generally apply to transactions of a nature and kind similar to the Transaction and have been adopted in good faith by Dealer for Dealer to refrain from or decrease any market activity in connection with the Transaction. Settlement: