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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 […]
January 27, 2023
Published by Med Search on January 27, 2023
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Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Download the Final Guidance Submit Comments Submit comments on this guidance document electronically via docket […]
January 27, 2023
Published by Med Search on January 27, 2023
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Reference #: 3002759467 Product: Drugs Recipient: Recipient Name Mr. Jonathan Zrihen Recipient Title CEO Laboratoires Clarins Clarins Group 12, avenue de la Porte-des-Ternes75017 ParisFrance Issuing Office: […]
January 27, 2023
Published by Med Search on January 27, 2023
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Product: Drugs Recipient: Recipient Name Mr. Denis Martin Recipient Title Operations Director Laboratoires Clarins 5 rue Ampére95300 PontoiseFrance Issuing Office: Center for Drug Evaluation and Research […]
January 26, 2023
Published by Med Search on January 26, 2023
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On January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a […]
January 26, 2023
Published by Med Search on January 26, 2023
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Recognized Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales M100 standard is recognized Haemophilus influenzae and parainfluenzae […]
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