Info Obat dan Regulator Obat Dunia

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Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products
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273
FDA
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Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
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400
FDA
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Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast
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264
FDA
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Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
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432
FDA
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Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics
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240
FDA
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Pediatric Exclusivity Granted
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336
FDA
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"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases - 630976 - 04/05/2022
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237
FDA
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Vi-Jon, LLC - 622087 - 03/31/2022
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310
FDA
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Elements Brands Inc. - 628380 - 04/13/2022
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258
FDA
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Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. - 628399 - 04/13/2022
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477
FDA
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Ultimark Products - 628389 - 04/13/2022
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297
FDA
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FDA works to protect consumers from potentially harmful OTC skin lightening products
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274
FDA
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Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy - 555295 - 09/19/2018
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243
FDA
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Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy - 555295 - 04/04/2022
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243
FDA
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Duoc Thao Tre Xanh, LLC - 611685 - 03/16/2021
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264
FDA
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Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?
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224
FDA
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Research Investigational New Drug Applications – What You Need To Know
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423
FDA
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FDA Modernizes Clinical Trials with Master Protocols
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257
FDA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 April 2022, CVMP, 19/04/2022
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301
EMA
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Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet
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300
FDA
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