Expanded Access definition

Expanded Access means access to specifically identified information in the eCourt case management system that is not available to the general public and might include access to personally identifiable information.
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Expanded Access means any procedures, such as compassionate use, parallel track, and treatment protocols that distribute drugs to patients who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
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Expanded Access means access to specifically identified in- formation in the eCourt case management system that is not available to the general public and might include access to per- sonally identifiable information.
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Examples of Expanded Access in a sentence

  • Payment of the Expanded Access Fee by CytomX to ImmunoGen shall be made in U.S. Dollars without set-off or counterclaim and free and clear of any taxes, duties, levies, fees or charges.

  • 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 Relying Institution will establish a mechanism that allows human subjects and others to report concerns about the conduct of the Expanded Access IND.

  • The Company is conducting a Phase 2b clinical trial using Trappsol® Cyclo™ intravenously in early Alzheimer’s disease (NCT05607615) based on encouraging data from an Expanded Access program for Alzheimer’s disease (NCT03624842).

  • The Relying Institution will also oversee the safe and appropriate conduct of the Expanded Access IND at its institution and will ensure compliance with applicable federal, state, local or institutional requirements related to the protection of human subjects, which may include investigating and managing any incidence, experience, or outcome that may rise to the level of an unanticipated problem and/or serious or continuing noncompliance.

  • This information should be communicated to the CDC IRB through the CDC Principal Investigator and may be considered by the CDC IRB if the Relying Institution requests a change or deviation from the approved Expanded Access IND.

  • The Relying Institution will also provide all information about the conduct of the Expanded Access IND at the Relying Institution that the CDC IRB requires to meet its review and reporting requirements.

  • Communicate to the CDC IRB the requirements of all applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, relevant to the Expanded Access IND (“Local Context Considerations”) that would affect the conduct or approval of the investigation at the Relying Institution.

  • The Relying Institution may not initiate, change, or deviate from the approved Expanded Access IND, informed consent, or other approved materials, except where necessary to eliminate apparent immediate hazards to subjects, without first receiving prior approval from the CDC IRB.

  • Generally, these sections pertain to availability of treatment and compensation for Expanded Access IND-related injury, payment or reimbursement of Expanded Access IND-related costs incurred by human subjects, and local contact information.


More Definitions of Expanded Access

Expanded Access. PROGRAM shall mean the Roche program initiated for limited, pre-FDA approval distribution of Fuzeon for qualified compassionate use patients.
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Related to Expanded Access

  • 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.

  • Restricted Access Area means a building, room, or other contiguous area on the premises where plant material is grown, cultivated, harvested, stored, packaged, or processed for sale under control of the manufacturer, and where no person under the age of 18 is permitted.

  • 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 of 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.

  • Limited access highway means a highway:

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