(Total Views: 642)
Posted On: 05/30/2021 4:45:28 AM
Post# of 153902
a poster on ymb has received a reply from the fda and then poster responded to fda reply
Received response from FDA on my letter regarding the authenticity of the FDA statement in less than 24 hours!
Thank you for writing the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.
Please understand that the regulations you have sited apply to current good manufacturing practices (cGMP) for drug products, not to statements from FDA.
Although FDA generally cannot disclose confidential information about unapproved products, we have concluded that given the significant public interest in leronlimab, it was important to provide summary information about the status of the CytoDyn development program. We appreciate your feedback on our statement and will provide it to the appropriate group at FDA for consideration.
Best Regards,
MM
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
My response to them:
Hi MM,
I hope you are doing well and staying safe.
I sincerely appreciate the prompt response from FDA. However, I disagree with the response for the following reasons:
1. Good documentation practices ( Name of the author, reviewer, approver, references etc.) applies to all kind of communications and documentation within the regulatory sphere including drug products, drug substances, devices, etc. As Leronlimab is a drug product, it will fall under the current good manufacturing practices regulations.
2. The response lacks the reasons for not including several key aspects of the trials - CD-10 mild to moderate study meeting the NEWS2 endpoint, 14-day mortality pre-established secondary endpoints of the CD12, etc.
3. The FDA statement did not provide the status of the development program, but intentionally made conclusions of the trials based on selected data.
As US Citizens, we would like to know the author, reviewer, and approver of this statement and what process was involved in drafting this statement which highlighted only the negative aspects of the trial and left out positives in this pandemic.
Please guide me on who to contact to get the above information.
Thanks again for your response
Received response from FDA on my letter regarding the authenticity of the FDA statement in less than 24 hours!
Thank you for writing the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.
Please understand that the regulations you have sited apply to current good manufacturing practices (cGMP) for drug products, not to statements from FDA.
Although FDA generally cannot disclose confidential information about unapproved products, we have concluded that given the significant public interest in leronlimab, it was important to provide summary information about the status of the CytoDyn development program. We appreciate your feedback on our statement and will provide it to the appropriate group at FDA for consideration.
Best Regards,
MM
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
My response to them:
Hi MM,
I hope you are doing well and staying safe.
I sincerely appreciate the prompt response from FDA. However, I disagree with the response for the following reasons:
1. Good documentation practices ( Name of the author, reviewer, approver, references etc.) applies to all kind of communications and documentation within the regulatory sphere including drug products, drug substances, devices, etc. As Leronlimab is a drug product, it will fall under the current good manufacturing practices regulations.
2. The response lacks the reasons for not including several key aspects of the trials - CD-10 mild to moderate study meeting the NEWS2 endpoint, 14-day mortality pre-established secondary endpoints of the CD12, etc.
3. The FDA statement did not provide the status of the development program, but intentionally made conclusions of the trials based on selected data.
As US Citizens, we would like to know the author, reviewer, and approver of this statement and what process was involved in drafting this statement which highlighted only the negative aspects of the trial and left out positives in this pandemic.
Please guide me on who to contact to get the above information.
Thanks again for your response
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