Adverse Drug Experience Report definition

Adverse Drug Experience Report means any oral, written or electronic report of any Adverse Drug Experience transmitted to any Person.
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Adverse Drug Experience Report means any oral, written or electronically transmitted report of any "adverse drug experience" (as defined in the FD&C Act, including, but not limited to, 21 C.F.R. 314.80 or 312.32), associated with the use of doxazosin mesylate (including the Product).
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Adverse Drug Experience Report means any oral, written or electronically transmitted report of any "adverse drug experience" as defined by 21 C.F.R. 314.80, associated with the use of the Product, and the term "Serious Adverse Drug Experience Report" shall mean any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias, or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
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Examples of Adverse Drug Experience Report in a sentence

  • See Office of Epidemiology and Biostatistics, Food andDrug Administration, Annual Adverse Drug Experience Report: 1996 (Oct.

  • Additionally, after the Closing, Seller shall assist Purchaser with the provision of data relating to adverse experiences for the Product, for Purchaser’s preparation of its first Periodic Adverse Drug Experience Report after the Closing.

  • From and after the Closing, Seller shall complete any outstanding commitments that Seller made to FDA prior to Closing with respect to Abstral, namely providing a Final Response to FDA on the issues identified in FDA Form 483 issued August 25, 2015 and a reconciled Periodic Adverse Drug Experience Report (PADER) for the period ending January 2015.

  • The post approval aggregate report is Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), and Periodic Safety Update Report (PSUR).

  • Acorda shall, in respect of a Collaboration Product: (i) notify Teva of all Serious Adverse Drug Experience Reports as soon as practicable, but in no event later than two (2) calendar days, after any Serious Adverse Drug Experience Report becomes known to it; and (ii) notify Teva of all Adverse Drug Experience Reports as soon as practicable, but in no event later than four (4) Business Days, after any Adverse Drug Experience Report becomes known to it.

  • We request that for a period of 5 years from the U.S. approval date, you provide detailed analyses of events of blood disorders and hepatic adverse events reported from clinical study and post-marketing reports in your periodic safety report (i.e., the Periodic Adverse Drug Experience Report [PADER] required under 21 CFR 314.80(c)(2) or the ICH E2C Periodic Benefit-Risk Evaluation Report [PBRER]format).

  • Morphabond Periodic Adverse Drug Experience Report 04- 03-16 to 07-02-16 (Q3).

  • We acknowledge receipt of your submission dated May 24, 2007 and to the related Addendum 1 to the Periodic Adverse Drug Experience Report 2007, dated May 24, 2007.

  • Exeltis, Periodic Adverse Drug Experience Report for Benznidazole Tablet, Dec/18/2018months after the commercial launch of benznidazole (Table 3).

  • Premarketing reportPost-marketing report • PeriodicBenefitRiskEvaluation Report (PBRER).• Periodic Safety Update Report (PSUR).• Periodic Adverse Drug Experience Report (PADER).• Development Safety Update Report.

Related to Adverse Drug Experience Report

  • 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 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.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • 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.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Peer-reviewed medical literature means a scientific study published only after having been critically

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Independent Engineering Report means a report, in form and substance satisfactory to the Administrative Agent and each of the Lenders, prepared by an Independent Engineer, addressed to the Administrative Agent and the Lenders with respect to the Oil and Gas Properties owned by the Borrower or its Subsidiaries (or to be acquired by the Borrower or any of its Subsidiaries, as applicable) which are or are to be included in the Borrowing Base, which report shall (a) specify the location, quantity, and type of the estimated Proven Reserves attributable to such Oil and Gas Properties, (b) contain a projection of the rate of production of such Oil and Gas Properties, (c) contain an estimate of the net operating revenues to be derived from the production and sale of Hydrocarbons from such Proven Reserves based on product price and cost escalation assumptions specified by the Administrative Agent and the Lenders, and (d) contain such other information as is customarily obtained from and provided in such reports or is otherwise reasonably requested by the Administrative Agent or any Lender.

  • 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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Evaluation Report means a report on the evaluation of tenders prepared under CSO 12

  • CREFC® Operating Statement Analysis Report The monthly report in the “Operating Statement Analysis Report” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Engineering Report means the Initial Engineering Report and each engineering report delivered pursuant to Section 6.2.

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.