Info Obat dan Regulator Obat Dunia

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Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling
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268
FDA
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Special Protocol Assessment Guidance for Industry
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231
FDA
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International Agreements & Information Sharing
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203
FDA
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FDA Listing of Authorized Generics
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217
FDA
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PDUFA Performance Reports
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0
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293
FDA
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American Bangster Black Label Optimum Formula 4000 contains hidden drug ingredient
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233
FDA
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Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry
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246
FDA
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Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the
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220
FDA
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Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guid
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419
FDA
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UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopro
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0
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390
FDA
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Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER): Real-World Evidence (RWE)
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216
FDA
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Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
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273
FDA
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New features further strengthen Priority Medicines scheme (PRIME), , 04/04/2023
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272
EMA
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FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19
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233
FDA
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Animal Model Qualification Program | AMQP
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188
FDA
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Overview of the Animal Model Qualification Program
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258
FDA
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EU recommendations for 2023-2024 seasonal flu vaccine composition, CHMP, 03/04/2023
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0
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261
EMA
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A Deep Dive: GDUFA III Scientific Meetings - 05/15/2023
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243
FDA
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Episciences Inc. - 631902 - 08/25/2022
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258
FDA
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Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products - 06/15/2023
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0
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308
FDA
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