Info Obat dan Regulator Obat Dunia

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FDA Compounding Quality Center of Excellence Cross-Sector Stakeholder Group
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550
FDA
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Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
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680
FDA
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In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
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583
FDA
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Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
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621
FDA
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IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommenda
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598
FDA
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FDA issues final guidance about multiple endpoints in clinical trials
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590
FDA
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In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
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564
FDA
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EMA recommends approval of second adapted Spikevax vaccine, CHMP, 19/10/2022
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584
EMA
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EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age, CHMP, 19/10/2022
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566
EMA
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Multiple Endpoints in Clinical Trials Guidance for Industry
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571
FDA
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Guidance Recap Podcast | Multiple Endpoints in Clinical Trials
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541
FDA
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FDA Clinical Investigator Training Course (CITC) 2022 - 12/07/2022
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587
FDA
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GDUFA User Fee Rates Archive
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596
FDA
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Advancing Real-World Evidence Program
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552
FDA
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Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
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571
FDA
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FDA NanoDay Symposium 2022 - 10/11/2022
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581
FDA
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CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
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694
FDA
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Tissue Agnostic Drug Development in Oncology
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637
FDA
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Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials
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565
FDA
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Remarks by FDA Commissioner Robert M. Califf to the 2022 NORD Breakthrough Summit - 10/17/2022
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626
FDA
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