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.

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. [**].

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.

Examples of Expanded Access Program in a sentence

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

• 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).

• 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.

• 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.

• 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.

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

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

• 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.

More Definitions of Expanded Access Program

Expanded Access Program means any plan under which a Governmental Authority authorizes preapproval access to any investigational drug or biologic for use by an individual.

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.

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.

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.”

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.