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May 19, 2021

FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments

FDA’s Clinical Methodologies Group (ClinMeth) within CDER’s Office of Medical Policy received a $9.2 million grant through the HHS Office of the Assistant Secretary for Planning […]
May 19, 2021

Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Expanded Recall of Dibar Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)

Summary Company Announcement Date: May 18, 2021 FDA Publish Date: May 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company […]
May 19, 2021

Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry

Submit Comments by 07/19/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 19, 2021

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

Docket Number: FDA-2008-D-0406 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is intended to assist […]
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 […]
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