Treatment IND definition

Treatment IND means treatment of a patient in accordance with an “Emergency Investigational New Drug Application” approval granted under 21 USC 312 or equivalent local law provision; Unavailable Target is defined in Clause 3.1.4;
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Treatment IND means an Investigational New Drug treatment used for Clinical Trial before the drug has been approved.
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Treatment IND means treatment Investigational New Drug Application authorized by competent authority (a) when used for a patient suffering from a chronic, severe or life-threatening disease for which no satisfactory authorized alternative therapy exists or (b) when otherwise approved for use by a competent regulatory authority for use for an individual under a doctor’s care but prior to the receipt of marketing approval of the product for any use.
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Examples of Treatment IND in a sentence

  • Treatment IND As discussed above,148 treatment IND and treatment protocol procedures existed informally for many years before FDA proposed formal regulations detailing agency practice in 1983.

  • Treatment IND studies require prospective IRB review and informed consent.

  • The stated purpose of the Treatment IND exemption is to facilitate the availability of promising new drugs to desperately ill patients while obtaining additional data on the drug's safety and effectiveness.

  • And he failed to provide a plausible explanation regarding how approval of the Treatment IND might interfere with clinical investigations; indeed, there is none.

  • Indeed, FDA has committed itself, in the U.S. Supreme Court and in other federal courts, to a policy of granting “nearly all” single-patient Treatment IND applications for terminally ill patients who lack alternative treatment options.

  • Section 312.42 in turn provides that clinical holds may be placed on proposed Treatment INDs if they fail to meet the criteria in§ 312.34(b) (set forth above) for obtaining a Treatment IND.

  • Trustee Armacost: On the welcome packets for new residents, one idea the Senior Council had is that they would like to offer a senior with the package to explain the history of the Village from the perspective of somebody who has been here for many years.

  • None of the reasons cited by Dr. Katz come anywhere near explaining why this is the exceptional case for which denial of such a Treatment IND would be justified.

  • A lice n sed p ra c t io n e r w h o r eceives an i n ves t ig a t io na l d ru g fo r t r e a tm e n t u se un de r a t r e a tm e n t p r o t ocol is an ‘‘i n ves t ig a t o r’’ un de r t h e p r o t ocol an d is r espo n sible fo r m ee t i n g a ll a pplic a- ble i n ves t ig a t o r r espo n sibili t ies un de rt h is p ar t an d 21 C F R p ar t s 50 an d 56.( b) Treatment IND submitted by li- censed practitioner.

  • Only by applying an inappropriate legal standard was Dr. Katz able to conclude that the Treatment IND should be rejected.


More Definitions of Treatment IND

Treatment IND means the treatment use of an investigational new drug pursuant to US 21 CFR § 312.34. SECTION II—
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Related to Treatment IND

  • Treatment zone means a soil area of the unsaturated zone of a land treatment unit within which hazardous constituents are degraded, transformed, or immobilized.

  • Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

  • Treatment means any method, technique, or process, including neutralization, designed to change the physical, chemical, or biological character or composition of any hazardous waste so as to neutralize such waste, or so as to recover energy or material resources from the waste, or so as to render such waste non-hazardous, or less hazardous; safer to transport, store, or dispose of; or amenable for recovery, amenable for storage, or reduced in volume.

  • Treatment program means an abstinence based program or facility that is accredited by any of the following:

  • Treatment plan means a written agreement between the department and the parent or

  • Maltreatment means the neglect, abuse, or financial exploitation of a vulnerable adult.

  • Treatment Plant means the onshore plant to be constructed by the Joint Venturers for the liquefaction and treatment of natural gas and condensate as contemplated in the recitals to this Agreement.

  • Mistreatment means the inappropriate use of medications, isolation, or use of physical or chemical restraints as punishment, for staff convenience, as a substitute for treatment or care, in conflict with a physician's order, or in quantities which inhibit effective care or treatment, which harms or is likely to harm the patient or resident.

  • Substance abuse treatment means outpatient or inpatient services or participation in Alcoholics Anonymous or a similar program.

  • Treatment works means any devices and systems used in storage, treatment, recycling, and reclamation of municipal sewage and industrial wastes, of a liquid nature to implement section 201 of the Act, or necessary to recycle reuse water at the most economic cost over the estimated life of the works, including intercepting sewers, sewage collection systems, pumping, power and other equipment, and alterations thereof; elements essential to provide a reliable recycled supply such as standby treatment units and clear well facilities, and any works, including site acquisition of the land that will be an integral part of the treatment process or is used for ultimate disposal of residues resulting from such treatment.

  • Sewage Treatment Plant means any arrangement of devices and structures used for treating sewage.

  • Treatment team means the group of individuals who formulate, assess, monitor and revise, as needed, the child's service plan. The treatment team shall include, but is not limited to:

  • Non-Administrator Substance Use Disorder Treatment Facility means a Substance Use Disorder Treatment Facility that does not meet the definition of an Administrator Substance Use Disorder Treatment Facility.

  • Treatment facility means an institution (or distinct part thereof) for the treatment of alcoholism or drug abuse, which meets fully every one of the following tests:

  • Opioid treatment program means a detoxification or maintenance treatment program which is required to report patient identifying information to the central registry and which is located in the state.

  • Wastewater treatment unit means a device which:

  • Wastewater treatment tank means a tank that is designed to receive and treat an influent wastewater through physical, chemical, or biological methods.

  • Negligent treatment or maltreatment means an act or a

  • Medical Treatment means examination and treatment by a Legally Qualified Physician for a condition which first manifested itself, worsened or became acute or had symptoms which would have prompted a reasonable person to seek diagnosis, care or treatment.

  • Active treatment means the implementation of an individualized care plan developed under and supervised by a physician and other qualified mental health professionals that prescribes specific therapies and activities.

  • Wastewater treatment system means any equipment, plants,

  • OPD treatment means the one in which the Insured visits a clinic / hospital or associated facility like a consultation room for diagnosis and treatment based on the advice of a Medical Practitioner. The Insured is not admitted as a day care or in-patient.

  • Thermal treatment means the treatment of hazardous waste in a device which uses elevated temperatures as the primary means to change the chemical, physical, or biological character or composition of the hazardous waste. Examples of thermal treatment processes are incineration, molten salt, pyrolysis, calcination, wet air oxidation, and microwave discharge. (See also “incinerator” and “open burning”.)

  • Pretreatment standards means all applicable Federal rules and regulations implementing Section 307 of the Act, as well as any nonconflicting State or local standards. In cases of conflicting standards or regulations, the more stringent thereof shall be applied.

  • National Treatment NT shall not apply to any measure affecting the type of activities which may be conducted on land or the usage of land, including but not limited to, land zoning, land use and urban planning policies. Urban Redevelopment Authority Act, Chapter 340, 1985 Revised Edition

  • Wastewater Treatment Works means an arrangement of devices and structures for treating wastewater, industrial wastes, and sludge. Sometimes used as synonymous with "waste treatment plant" or "wastewater treatment plant" or "pollution control plant".