Info Obat dan Regulator Obat Dunia

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GDUFA III Reauthorization
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563
FDA
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FDA Expands CDER NextGen Portal
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614
FDA
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Rare Disease Endpoint Advancement Pilot Program
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642
FDA
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Biosimilars | Science and Research
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555
FDA
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Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
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518
FDA
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FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld
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540
FDA
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Rare Disease Endpoint Advancement Pilot Program Frequently Asked Questions
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535
FDA
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FDA grants accelerated approval to futibatinib for cholangiocarcinoma
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546
FDA
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Innovation to Respond to COVID-19
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567
FDA
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BD Announces Voluntary Recall of ChloraPrep™ 3 mL Applicator in Specific U.S. Territories and Countries
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691
FDA
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PDUFA VI Commitment: Assessment in Support of Sentinel System
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534
FDA
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Food and Drug Administration Overdose Prevention Framework
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527
FDA
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EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products , , 29/09/2022
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544
EMA
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022, PRAC, 30/09/2022
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619
EMA
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New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome, PRAC, 30/09/2022
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653
EMA
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Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022, , 30/09/2022
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798
EMA
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The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | Audio Transcript
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535
FDA
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Industry Information and Guidance
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470
FDA
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The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
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520
FDA
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GDUFA II Enhanced Accountability & Reporting
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499
FDA
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