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November 17, 2020

COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

For Immediate Release: November 17, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D. […]
November 17, 2020

MXL Comercial, SA de CV – 609335 – 11/10/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Fernando Padilla Recipient Title Director General MXL Comercial, SA de CV Calle Cromo 206Col. Industrial del Norte37200 […]
November 17, 2020

Grupo Asimex de Mexico SA de CV – 609759 – 11/06/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Rogerio Pimentel Recipient Title Director Grupo Asimex de Mexico SA de CV Vazquez Mella 327 – […]
November 17, 2020

Family Pharmacy of Statesville, Inc. – 611664 – 11/06/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Joshua A. Eudy Recipient Title CEO Family Pharmacy of Statesville, Inc. 208 Old Mocksville RoadStatesville, NC […]
November 13, 2020

Certificates of Confidentiality

Docket Number: FDA-2019-D-3592 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Policy, Legislation, and International Affairs, Office of Policy Center for Biologics Evaluation […]
November 13, 2020

Remarks by Dr. Hahn to the Friends of Cancer Research Annual Meeting – 11/13/2020

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration [embedded content] Good afternoon.  It’s a pleasure to […]
November 13, 2020

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

On November 13, 2020, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of […]
November 13, 2020

Frequently Asked Questions about Drug Shortages

The following questions and answers are those that are most frequently asked and answered by the Center for Drugs and Evaluation and Research (CDER) Drug Shortage […]
November 12, 2020

DDT COA #000130: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Cutaneous Lupus Erythematosus

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Dermatology and Dentistry (DDD) DDT COA NumberDDT COA #000130 Instrument NameCutaneous Lupus Erythematosus Disease […]
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