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March 24, 2021

Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs: Questions and Answers

FDA is working to respond to questions from states regarding the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between state boards of […]
March 24, 2021

Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up

Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 24, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect Product Strength on […]
March 23, 2021

Coronavirus (COVID-19) Update: March 23, 2021

For Immediate Release: March 23, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
March 23, 2021

Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) | Infographic

Visualization of data associated with CDER’s response to the coronavirus (COVID-19) pandemic from January 1, 2020 – February 1, 2021 Download Printable PDF COVID-19 Therapeutic Development […]
March 23, 2021

PYRLess Group, LLC dba Dr. Fitt – 611424 – 01/25/2021

Product: Drugs Recipient: Recipient Name Christy McCord PYRLess Group, LLC dba Dr. Fitt 812 S Georgia StAmarillo, TX 79106United States [email protected] WARNING LETTER Date: February 25, […]
March 23, 2021

CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER is disclosing information from our scientific review […]
March 23, 2021

DEPQ Internacional S. de R.L de C.V. – 608871 – 03/18/2021

Delivery Method: VIA UPS Reference #: 320-21-36 Product: Drugs Recipient: Recipient Name Mr. Daniel Alberto Alfaro Saldaña DEPQ Internacional S. de R.L de C.V. Prol. Calzada […]
March 23, 2021

Anna Health, LLC – 613294 – 03/16/2021

Delivery Method: VIA Electronic Mail Product: Dietary SupplementsDrugs Recipient: Recipient Name Mr. Tin Huynh Recipient Title Registered Agent Anna Health, LLC 9724 N. Armenia Ave. Suite […]
March 23, 2021

Duoc Thao Tre Xanh, LLC – 611685 – 03/16/2021

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Tin Huynh Recipient Title Registered Agent Duoc Thao Tre Xanh, LLC 9724 N. Armenia Ave. […]
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