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

Examples of Expanded Access in a sentence

  • The Association of Expanded Access to a Collaborative Midwifery and Laborist Model With Cesarean Delivery Rates.

  • Charging For Expanded Access for Treatment UseThe proposed regulations would also replace the current regulation on charging for investigational drugs through a treatment IND or protocol.

  • Requirements for All Expanded Access UseIn all circumstances where expanded access use is permitted, FDA would require that the patient or patients seeking treatment have a “serious or immediately-life threatening disease or condition” with no comparable or satisfactory alternative therapy.277 FDA would need to determine that the potential patient benefit justifies the potential risks of treatment use, and that276 Id. at 75149-75150.277 Id. at 75150-75151.

  • Expanded Access for Individual PatientsIn addition to the criteria applicable to all expanded access uses, the proposed regulations detail specific criteria for different expanded access uses.

  • Level D – Expanded Access (inside the geographic allowance area).

  • Why is the Program Health Care Provider suggesting to give your child Stamaril vaccine instead of YF-VAX?In agreement with the US FDA, during the non-availability of YF-VAX, an alternative yellow fever vaccine, Stamaril, manufactured by Sanofi Pasteur but not licensed in the United States, can be used within this Expanded Access program.

  • Expenditures for the Expanded Access to Primary Care (EAPC) will be reduced by either the 13.95 percent factor as specified in subparagraph (a), or by the costs related to providing services to those individuals with aid codes used to designate non-qualified aliens.

  • A Power Purchase Agreement (PPA), after some amendments, came into existence between the Appellant and the then Andhra Pradesh State Electricity Board on 15.04.1998.

  • Considerations for Observational Studies and Expanded Access Records:https://clinicaltrials.gov/ct2/manage-recs/how-register#Considerations It takes approximately 1 hour to enter registration information.

  • Going "Social" to Access Experimental and Potentially Life-Saving Treatment: An Assessment of the Policy and Online Patient Advocacy Environment for Expanded Access.


More Definitions of Expanded Access

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.

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 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.

  • 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:

  • 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.

  • Unauthorized Access means the entrance of a person into a restricted area without permission of the operator or the operator’s designated representative.

  • Landlord Access Agreement means a Landlord Access Agreement, substantially in the form of Exhibit G, or such other form as may reasonably be acceptable to the Administrative Agent.

  • 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.

  • 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;

  • L/C Amendment Application means an application form for amendment of outstanding standby or commercial documentary letters of credit as shall at any time be in use at the Issuing Bank, as the Issuing Bank shall request.

  • 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;

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

  • 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.

  • Fourth Amendment Effective Date has the meaning assigned to such term in the Fourth Amendment.

  • Open Access means the non-discriminatory provision for the use of transmission lines or distribution system or associated facilities with such lines or system by any licensee or consumer or a person engaged in generation in accordance with the regulations specified by the Appropriate Commission;

  • Development Credit Agreement means the agreement of even date herewith between the Borrower and the Association for the Project, as such agreement may be amended from time to time; and such term includes all schedules and agreements supplemental to the Development Credit Agreement.

  • Lateral Access Road Licence means a miscellaneous licence granted pursuant to subclause (6)(a)(ii) or subclause (6)(b) as the case may be and according to the requirements of the context describes the area of land from time to time the subject of that licence;

  • Third Amendment Effective Date shall have the meaning provided in the Third Amendment.

  • Second Amendment Effective Date has the meaning assigned to such term in the Second Amendment.

  • Ninth Amendment Effective Date has the meaning set forth in Section 4 of the Ninth Amendment.

  • 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.

  • Increased Facility Activation Notice means a notice substantially in the form of Exhibit E.

  • Interconnection Activation Date means the date that the construction of the joint facility Interconnection arrangement has been completed, trunk groups have been established, joint trunk testing is completed and trunks have been mutually accepted by the Parties.

  • First Amendment Effective Date has the meaning assigned to such term in the First Amendment.

  • Fifth Amendment Effective Date shall have the meaning provided in the Fifth Amendment.