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January 31, 2023
Published by Med Search on January 31, 2023
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Submit Comments by 04/01/2023 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 […]
January 31, 2023
Published by Med Search on January 31, 2023
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[20/01/2023] En un esfuerzo por mejorar el suministro de ibuprofeno preparado en suspensión oral en medio de una demanda récord, la FDA está publicando una guía […]
January 31, 2023
Published by Med Search on January 31, 2023
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Recognized Interpretive Criteria Exceptions to the recognized standard of CLSI M100 Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales […]
January 31, 2023
Published by Med Search on January 31, 2023
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FDA Identified Breakpoints Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameters in mm) Pathogen S I R S I R Enterobacteralesa,b M-100 standard is recognized Pseudomonas […]
January 31, 2023
Published by Med Search on January 31, 2023
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Docket Number: FDA-2009-D-0125 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is intended to provide […]
January 30, 2023
Published by Med Search on January 30, 2023
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IMPACT INNOVATION PREDICTABILITY ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2020 New Drug Therapy Approvals 2019 (PDF-2.45MB) Content Introduction2019: Another Strong Year for Innovation and AdvancesNovel […]
January 30, 2023
Published by Med Search on January 30, 2023
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Summary Company Announcement Date: January 27, 2023 FDA Publish Date: January 30, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of […]
January 30, 2023
Published by Med Search on January 30, 2023
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The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with industry. This update clarifies that a face-to-face […]
January 30, 2023
Published by Med Search on January 30, 2023
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Docket Number: FDA-2022-D-2658 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to provide recommendations to sponsors regarding […]
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