Info Obat dan Regulator Obat Dunia

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EMA Management Board: highlights of October 2022 meeting, MB, 07/10/2022
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593
EMA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022, CVMP, 07/10/2022
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640
EMA
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GDUFA Guidances and MAPPs
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559
FDA
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Chair of the European Network of Paediatric Research at EMA re-elected, , 05/10/2022
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550
EMA
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GDUFA III Drug Master File (DMF) Review Enhancements
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571
FDA
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FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute
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552
FDA
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Facility Readiness: Goal Date Decisions Under GDUFA
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573
FDA
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FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule
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579
FDA
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Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
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617
FDA
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Call for expression of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee, PDCO, 05/10/2022
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725
EMA
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Competitive Generic Therapies
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549
FDA
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Drug Development Tools | DDTs
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561
FDA
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Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
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561
FDA
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Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding
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594
FDA
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El fluorouracilo y la seguridad de las mascotas
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526
FDA
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FDA Health Playbook
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592
FDA
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Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019
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709
FDA
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Sterling Pharmaceutical Services, LLC - 629019 - 09/27/2022
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598
FDA
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Designating an Orphan Product: Drugs and Biological Products
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529
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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