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May 18, 2021

Remarks by FDA Acting Commissioner Janet Woodcock to the FDLI Annual Conference – 05/18/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration [embedded content] (Remarks as prepared for delivery) Thank you Daniel […]
May 18, 2021

North American Hirudin Biotech Products Inc. – 613103 – 04/21/2021

Delivery Method: Overnight Delivery Product: Drugs Recipient: Recipient Name Zengxun An Recipient Title President North American Hirudin Biotech Products Inc. 2531 Broadway, Suite AEverett, WA 98201United […]
May 18, 2021

NeuroHydrate LLC – 613092 – 04/27/2021

Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name Mr. Hamid Sami Recipient Title Founding Partner NeuroHydrate LLC 4637 Main St, Unit 5Bridgeport, CT 06606-1838United […]
May 17, 2021

Statement on Leronlimab

FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment of COVID-19, especially those medicines that may provide a […]
May 17, 2021

Recall Expansion of Durisan Non-Alcohol Hand Sanitizer

Summary Company Announcement Date: May 14, 2021 FDA Publish Date: May 17, 2021 Product Type: Drugs Contaminants Reason for Announcement: Recall Reason Description Product is contaminated […]
May 17, 2021

Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation

Image By: RADM Denise Hinton, Chief Scientist, and Tina Morrison, Ph.D., Director, Office of Regulatory Science and Innovation We live in an era of rapidly changing […]
May 17, 2021

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

Docket Number: FDA-2021-D-0409 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays […]
May 14, 2021

FDA approves new treatment for adults with serious rare blood disease

FDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. Empaveli is the first PNH treatment that […]
May 14, 2021

Coronavirus (COVID-19) Update: May 14, 2021

For Immediate Release: May 14, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
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