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October 24, 2022
Published by Med Search on October 24, 2022
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What’s New 3/9/2022 – FDA established a docket to solicit comments on changes to FDA’s previously proposed Quality Metrics Reporting program. This notice describes considerations for […]
October 24, 2022
Published by Med Search on October 24, 2022
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What’s New GDUFA III enhancements for Type II API DMFs start on 10/1/2022 Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed […]
October 24, 2022
Published by Med Search on October 24, 2022
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On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). […]
October 24, 2022
Published by Med Search on October 24, 2022
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Cefazolin is a first-generation cephalosporin for parenteral administration that is indicated for the treatment of a number of bacterial infections including urinary tract infections. 1 In February […]
October 21, 2022
Published by Med Search on October 21, 2022
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Docket Number: FDA-2022-D-1270 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants who submit abbreviated new drug […]
October 21, 2022
Published by Med Search on October 21, 2022
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Docket Number: FDA-2022-D-1270 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants who submit abbreviated new drug […]
October 21, 2022
Published by Med Search on October 21, 2022
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Docket Number: FDA-2021-D-1140 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
October 21, 2022
Published by Med Search on October 21, 2022
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Docket Number: FDA-2021-D-1140 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
October 21, 2022
Published by Med Search on October 21, 2022
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Today, FDA issued the Multiple Endpoints in Clinical Trials Final Guidance for Industry. This final guidance provides sponsors and review staff with the Agency’s thinking about […]
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