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Posted On: 09/08/2023 5:35:44 PM
Post# of 148892
If CYDY really has a better relationship now with the FDA, perhaps this could lead to something. On the other hand, with such limited manpower, CYDY may not be in a position to respond to this type of request.
FDA maintains Covid flexibilities for IRB review of expanded access drugs for individuals
The FDA indicated that it will maintain some pandemic-era flexibilities in institutional review board (IRB) assessments of expanded access drugs for individual patients in immediately-in-effect guidance published Friday.
The FDA explains in the eight-page guidance that expanded access drugs refers to investigational drugs that serve the main purpose of treating, diagnosing or monitoring a patient’s disease as opposed to gleaning information about the drug, which is generally the main purpose of a clinical trial.
FDA regulations outline three categories of expanded access submissions: Individual patient, including submissions for emergency use; submissions for populations of intermediate size; and “‘treatment’ for larger populations.” The guidance published Friday only applies to the review of requests for expanded access for individual patients, FDA clarifies.
Licensed physicians can submit patient expanded access requests to FDA as an investigational new drug (IND) application. Sponsors with an existing IND can submit the request as a protocol amendment, either on an emergency or non-emergency basis.
“A request for emergency individual patient expanded access does not require prior IRB review, but the IRB must be notified within 5 working days of treatment initiation,” FDA says. The agency typically signs off on more than 99% of such expanded access requests every year, but occasionally patients cannot obtain access to investigational drugs via expanded access due to sponsor concerns.
Licensed physicians seeking non-emergency expanded access for a single patient can ask FDA to waive the requirement of full IRB review. FDA says it will generally allow for waivers if the IRB chairperson or a designated IRB member concurs before the treatment begins.
“IRB review of an expanded access submission for an individual patient, including review by a designated single member of the IRB under a waiver, should focus on the key factors needed to assess the risks and benefits of treatment for the particular patient involved,” the guidance states.
The guidance lays out several guidelines for IRBs when determining whether to grant expanded access for a single patient. It directs IRBs to establish procedures for reviewing non-emergency single patient expanded access requests if the physician requests to waive the requirements.
The guidance also recommends that IRBs focus on assessing the risks and benefits for the patient involved when reviewing expanded access requests.
https://endpts.com/fda-maintains-covid-flexib...dividuals/
FDA maintains Covid flexibilities for IRB review of expanded access drugs for individuals
The FDA indicated that it will maintain some pandemic-era flexibilities in institutional review board (IRB) assessments of expanded access drugs for individual patients in immediately-in-effect guidance published Friday.
The FDA explains in the eight-page guidance that expanded access drugs refers to investigational drugs that serve the main purpose of treating, diagnosing or monitoring a patient’s disease as opposed to gleaning information about the drug, which is generally the main purpose of a clinical trial.
FDA regulations outline three categories of expanded access submissions: Individual patient, including submissions for emergency use; submissions for populations of intermediate size; and “‘treatment’ for larger populations.” The guidance published Friday only applies to the review of requests for expanded access for individual patients, FDA clarifies.
Licensed physicians can submit patient expanded access requests to FDA as an investigational new drug (IND) application. Sponsors with an existing IND can submit the request as a protocol amendment, either on an emergency or non-emergency basis.
“A request for emergency individual patient expanded access does not require prior IRB review, but the IRB must be notified within 5 working days of treatment initiation,” FDA says. The agency typically signs off on more than 99% of such expanded access requests every year, but occasionally patients cannot obtain access to investigational drugs via expanded access due to sponsor concerns.
Licensed physicians seeking non-emergency expanded access for a single patient can ask FDA to waive the requirement of full IRB review. FDA says it will generally allow for waivers if the IRB chairperson or a designated IRB member concurs before the treatment begins.
“IRB review of an expanded access submission for an individual patient, including review by a designated single member of the IRB under a waiver, should focus on the key factors needed to assess the risks and benefits of treatment for the particular patient involved,” the guidance states.
The guidance lays out several guidelines for IRBs when determining whether to grant expanded access for a single patient. It directs IRBs to establish procedures for reviewing non-emergency single patient expanded access requests if the physician requests to waive the requirements.
The guidance also recommends that IRBs focus on assessing the risks and benefits for the patient involved when reviewing expanded access requests.
https://endpts.com/fda-maintains-covid-flexib...dividuals/
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