Recipient:
Cyrus Arman, Ph.D., M.B.A.
President
CytoDyn, Inc.
1111 Main Street
Suite 660
Vancouver, WA 98660
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Dr. Arman:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 11, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance or through other means.
If you have any questions or comments, please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 3 in addition to the IND number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov.
Sincerely,
{See appended electronic signature page}
Samuel M. Skariah, PharmD, RAC
Team Lead
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
/s/
SAMUEL M SKARIAH
04/27/2023 02:50:30 PM
Cyrus Arman, Ph.D., M.B.A.
President
CytoDyn, Inc.
1111 Main Street
Suite 660
Vancouver, WA 98660
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Dr. Arman:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 11, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance or through other means.
If you have any questions or comments, please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 3 in addition to the IND number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov.
Sincerely,
{See appended electronic signature page}
Samuel M. Skariah, PharmD, RAC
Team Lead
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
/s/
SAMUEL M SKARIAH
04/27/2023 02:50:30 PM
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