Expanded Access Program definition

Expanded Access Program means the administration of the Product to named individuals who do not meet the clinical trial enrollment criteria either outside of a clinical trial or after the completion of a clinical trial. Expanded Access Programs are also known as named patient programs, named patient supply, and temporary authorization for use.
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Expanded Access Program means the ability to make available an investigational drug to patients prior to marketing approval of the investigational drug in a given region, as described in Title 21, Sec. 312.300 et seq. of the C.F.R. for the United States, Article 83 of Regulation (EC) No. 726/2004 for the European Union and similar regulatory mechanisms in the individual member states, and similar foreign regulatory mechanisms of other Governmental Entities. [**].
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Expanded Access Program or “EAP” means an FDA-authorized clinical trial for the treatment use of an Investigational Product in patients who are not candidates to participate in any research trial for the particular Investigational Product.
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Examples of Expanded Access Program in a sentence

  • Currently, USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) is administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the US under an Expanded Access Program (EAP).

  • We previously paid a 4% royalty under our agreement for all cost-recovery that we receive under the Expanded Access Program.

  • The program involves 40 Phase I, 4 Phase II, and 15 Phase III/IIIb clinical trials as well as a Named Patient Program and an Expanded Access Program.

  • Obtaining Convalescent Plasma for the U.S. COVID-19 Expanded Access Program.

  • The number of times in which all eligibility criteria for the patient and the drug are met, and all parties agree to proceed, will be limited, however, in such scenarios, RTT provides a pathway which is far simpler and requires far less consultation, documentation, and reporting than the FDA’s Expanded Access Program, thus facilitating access to eligible investigational agents for eligible patients.

  • Licensee shall record the lot number of each Product used for each promotion and marketing event, distributed to each named patient in an Expanded Access Program, or sold to each customer, and shall retain all such records for [ * ] after the date of termination or expiration of this Supply Agreement to facilitate in the event of a Recall under Section 5.9 of the Collaboration and License Agreement.

  • He was an investigator on the Epidiolex Expanded Access Program published in The Lancet Neurology in 2016.

  • Feit NZ, Goldman DA, Smith E, et al: Use, Safety, and Efficacy of Single-Patient Use of the US Food and Drug Administration Expanded Access Program.

  • The U.S. Food and Drug Administration (FDA) initially approved an Expanded Access Program (EAP) [12] for the treatment of COVID-19 using plasma from individuals with a neutralization titer of 1:160 or higher.

  • Malignant peritoneal mesothelioma-Results from the International Expanded Access Program using pemetrexed alone or in combination with a platinum agent.


More Definitions of Expanded Access Program

Expanded Access Program or “EAP” means the activities required to enable Expanded access to investigational medical treatments and for the collection and analysis of RWD (as defined below). This includes activities directed to (i) the education of physicians regarding the possibility of Expanded access to investigational medical treatments that are not yet the subject of a Marketing Authorization through named- patient use, hospital exemption or compassionate use, (ii) patient enrollment, (iii) the securing of Expanded Access Approvals, for the use of such treatments, (iv) the collection and analysis of patient level data for research purposes, (v) pharmacovigilance registration and/or (vi) the collection of data, including but not limited to patient-reported outcomes and doctor-reported experiences.
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Expanded Access Program or “EAP” means the activities required to enable Expanded access to investigational medical treatments and for the collection and analysis of RWD (as defined below). This includes activities directed to (i) the education of physicians regarding the possibility of Expanded access to investigational medical treatments that are not yet the subject of a Marketing Authorization through named-patient use, hospital exemption or compassionate use, (ii) patient enrollment, (iii) the securing of Expanded Access Approvals, for the use of such treatments, (iv) the collection and analysis of patient level data for research purposes, (v) pharmacovigilance registration and/or (vi) the collection of data, including but not limited to patient-reported outcomes and doctor-reported experiences.
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Expanded Access Program means the activities conducted under CYP-001 (otherwise known as the clinical trial identified by XxxxxxxxXxxxxx.xxx as NCT04074512), as further described in Exhibit A-1.
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Expanded Access Program means the use of investigational new drug products outside of Clinical Trials to treat patients with serious or immediately life-threatening disease or conditions when there are no comparable or satisfactory alternative treatment options, as described in 21 CFR Section 312.305 or comparable Applicable Laws in jurisdictions outside the U.S. “Expanded Access Program” includes so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales.”
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Related to Expanded Access Program

  • Access Provider in this RAO means the Access Provider stated in the cover of this RAO who owns or provides the Access Service listed in the Access List and who is a Licensee as defined in the Act.

  • Switched Access Detail Usage Data means a category 1101xx record as defined in the EMI iconectiv Practice BR 010-200-010.

  • Switched Access Service means an offering of facilities for the purpose of the origination or termination of traffic from or to Exchange Service customer in a given area pursuant to a Switched Access tariff. Switched Access Services include: Feature Group A, Feature Group B, Feature Group D, 800 Series, and 900 access. Switched Access does not include traffic exchanged between LECs for purpose of local exchange interconnection.

  • Restricted access area means a designated and secure area within a Licensed Premises in a Retail Marijuana Store where Retail Marijuana and Retail Marijuana Product are sold, possessed for sale, and displayed for sale, and where no one under the age of 21 is permitted.

  • Limited access area means a building, room, or other contiguous area upon the Licensed Premises where Retail Marijuana is grown, cultivated, stored, weighed, packaged, sold, or processed for sale, under control of the Licensee.

  • Service Level Agreement (SLA means the Contractual Commitment that prevails between the Buyer and the Service Provider with regard to type of service to be provided, deliverables, desired performance level, reliability and responsiveness, monitoring process and service level reporting, response and issue resolution time-frame, repercussions / penalties / remedies for service provider not meeting its commitment. The SLA of a particular contract may carry the matrix regarding the delivery of the goods and/or services and the corresponding penalties or remedies and liquidated damages as applicable.

  • Controlled-access highway means every street or highway in respect to which owners or occupants of abutting lands and other persons have no legal right or access to or from the same except at such points only and in such manner as may be determined by the public authority having jurisdiction over such street or highway. (ORC 4511.01(CC))

  • Limited access highway means a highway:

  • Service Level Agreement or SLA means the processes, deliverables, key performance indicators and performance standards relating to the Services to be provided by the Service Provider;

  • Terms of Use means any privacy policy, terms of use or other terms and conditions made applicable by BNYM in connection with the Company’s or a Permitted User’s access to and use of a Component System or a BNYM Web Application or other access site or access method.

  • Optional Extended Local Calling Scope Arrangement Traffic is traffic that under an optional Extended Local Calling Scope Arrangement chosen by the Customer terminates outside of the Customer’s basic exchange serving area.

  • Access Card means an ATM card, debit card or credit card and includes our Visa Card

  • Carrier Access Billing System (“CABS”) is the system which is defined in a document prepared under the direction of the Billing Committee of the OBF. The CABS document is published by Telcordia in Volumes 1, 1A, 2, 3, 3A, 4 and 5 as Special Reports SR-OPT-001868, SR-OPT-0011869, SR-OPT-001871, SR-OPT- 001872, SR-OPT-001873, SR-OPT-001874, and SR-OPT-001875, respectively, and contains the recommended guidelines for the billing of access and other connectivity services. Sprint’s carrier access billing system is its Carrier Access Support System (CASS). CASS mirrors the requirements of CABS.

  • Open Access Customer means a consumer permitted by the Commission to receive supply of electricity from a person, other than Distribution Licensee of his area of supply, and the expression includes a generating company and a Licensee, who has availed of or intends to avail of open access;

  • the Scottish Infected Blood Support Scheme means the scheme of that name administered by the Common Services Agency (constituted under section 10 of the National Health Service (Scotland) Act 1978(b));

  • Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto.

  • End User Agreement means any agreement that Eligible Users are required to sign in order to participate in this Contract, including an end user agreement, customer agreement, memorandum of understanding, statement of work, lease agreement, service level agreement, or any other named separate agreement.

  • Child support services means any civil, criminal or administrative action taken by the Division of

  • Licensed facility means a facility licensed by the department under section 137 or an adult foster care facility.

  • Access Tandem Switch is a Switch used to connect End Office Switches to interexchange Carrier Switches. Qwest's Access Tandem Switches are also used to connect and switch traffic between and among Central Office Switches within the same LATA and may be used for the exchange of local traffic.

  • User Interface(s means any technologies thatiii. Customer owns and/or for which Customer has secured an appropriate license/subscription and is/areiv. used to develop/manage user interaction features and characteristics for ERP. Solely for clarity regarding ERP licensing requirements under a contract, User Interfaces for ERP shall be deemed part of ERP and therefore require human users Using ERP via such User Interfaces to have a “Named User” and/or “User” license for ERP, as applicable.

  • Terms-of-service agreement means an agreement that controls the relationship between a user and a custodian.

  • Data Processing Addendum means Sprinklr’s Data Processing Addendum, located at www.sprinklr.com/legal

  • Network Data Mover (NDM) or “Connect Direct” means the industry standard protocol for transferring information electrically.

  • Data Processing Lease means any lease or licensing agreement, binding on the Failed Bank as of Bank Closing, the subject of which is data processing equipment or computer hardware or software used in connection with data processing activities. A lease or licensing agreement for computer software used in connection with data processing activities shall constitute a Data Processing Lease regardless of whether such lease or licensing agreement also covers data processing equipment.

  • Wireless provider means a wireless infrastructure provider or a wireless services provider.