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May 26, 2023
Published by Med Search on May 26, 2023
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Submit Comments by 08/24/2023 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 26, 2023
Published by Med Search on May 26, 2023
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Yiwu Mango Cosmetics, Ltd.(China) Instant Hand Sanitizer (Alcohol 75%) 76824-001-0176824-001-0276824-001-0376824-001-0476824-001-0576824-001-0676824-001-0776824-001-0876824-001-0976824-001-1076824-001-1176824-001-1276824-001-13 Yiwu Mango Cosmetics, Ltd.(China) Product manufactured at a facility that did not respond to multiple FDA […]
May 26, 2023
Published by Med Search on May 26, 2023
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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 […]
May 25, 2023
Published by Med Search on May 25, 2023
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Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, […]
May 25, 2023
Published by Med Search on May 25, 2023
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Minimum InhibitoryConcentrations (mcg/mL) Disk Diffusion(zone diameters in mm) Pathogen S I R S I R Acinetobacter-baumannii calcoaceticus complex ≤ 4/4 8/4 ≥ 16/4 ≥ 17 […]
May 25, 2023
Published by Med Search on May 25, 2023
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For Immediate Release: May 25, 2023 Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral […]
May 25, 2023
Published by Med Search on May 25, 2023
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FDA actions to continue to ensure the safety of the nation’s drug supply By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research One […]
May 25, 2023
Published by Med Search on May 25, 2023
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CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies Decentralized clinical trials and digital health technologies are gaining momentum in medical research, […]
May 24, 2023
Published by Med Search on May 24, 2023
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Docket Number: FDA-2014-D-0092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking […]
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