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Ex. F: Department of Health & Human Services, Food and Drug Administration to Simone Gold, October 13, 2020 — No. 2:21-cv-00702 (Dkt. 15-6)

Summary

Ex. F, filed as Document 15-6 on 07/19/21 in Case 2:21-cv-00702-CLM, is an October 13, 2020 letter from the Food and Drug Administration to Simone Gold of America's Frontline Doctors. It acknowledges receipt on 10/13/2020 of a petition asking the Commissioner to exempt Plaquenil and equivalent hydroxychloroquine sulfate based drugs from prescription-dispensing requirements under 21 U.S.C. § 353(b)(3) and 21 C.F.R. § 310.200(b), and assigns docket number FDA-2020-P-2066. The letter says accepting the petition for filing is a procedural matter that reflects no agency decision on its merits; it is signed by Dynna Bigby of FDA's Dockets Management Staff.

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“Ex. F: Department of Health & Human Services, Food and Drug Administration to Simone Gold, October 13, 2020 — No. 2:21-cv-00702 (Dkt. 15-6).” Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/gov-uscourts-alnd-177186-15-6-0710563382/, SHA-256 7446ae2619211b7c2535fe2ea3d20bce3a53900ae16f0cc227ec1ce5534860ef.

Full text

Case 2:21-cv-00702-CLM Document 15-6 Filed 07/19/21 Page 1 of 1 Ex. F FILED
* 2021 Jul-19 PM 01:01
DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. DISTRICT COURT
N.D. OF ALABAMA
Food and Drug Administration
Rockville, MD 20857
October 13, 2020
Simone Gold
America's Frontline Doctors
c/o Free Speech Foundation
2934-1/2 Beverly Glen Circle #314
Los Angeles, CA 90077
Sent via email to: info@aflds.com
Dear Petitioner:
Your petition to the Commissioner of Food and Drug Administration requests to exempt
from prescription-dispensing requirements, pursuant to 21 U.S.C. § 353(b)(3) and 21
C.F.R. § 310.200(b), Plaquenil™ and equivalent hydroxychloroquine sulfate based drugs
was received by this office on 10/13/2020.
It was assigned docket number FDA-2020-P-2066. Please refer to this docket number in
future correspondence on this subject with the Agency.
Please note that the acceptance of the petition for filing is a procedural matter in that it in
no way reflects an agency decision on the substantive merits of the petition.
Sincerely,
Dynna Gorham-bigby -S Digitally signed by
Dynna Gorham-bigby -S
Date: 2020.10.22 12:51:28 -04'00'
Dynna Bigby
Supervisory Administrative Proceedings Officer
Dockets Management Staff
FDA/Office of Operations (OO)

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