Info Obat dan Regulator Obat Dunia

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Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” - 05/02/2023
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416
FDA
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FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
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217
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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308
FDA
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Identification of Medicinal Products — Implementation and Use
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344
FDA
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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamin
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226
FDA
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Procter & Gamble Manufactura S. de R.L. de C.V. - 650837 - 03/27/2023
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343
FDA
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Drug Disposal: Questions and Answers
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226
FDA
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Regulatory information – adjusted fees for applications to EMA from 1 April 2023, , 31/03/2023
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378
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023, CHMP, 31/03/2023
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256
EMA
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EMA recommends approval of Bimervax as a COVID-19 booster vaccine, CHMP, 30/03/2023
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225
EMA
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Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentratio
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294
FDA
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The History of Drug Regulation
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272
FDA
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Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Softw
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212
FDA
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2020 Meeting Materials, Psychopharmacologic Drugs Advisory Committee
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218
FDA
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FDA Approves First Over-the-Counter Naloxone Nasal Spray
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232
FDA
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OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration - 05/16/2023
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212
FDA
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Access to Naloxone Can Save a Life During an Opioid Overdose
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214
FDA
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FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance
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278
FDA
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DARWIN EU® has completed its first studies and is calling for new data partners, , 28/03/2023
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344
EMA
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NuGeneration Technologies LLC - 645821 - 03/13/2023
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287
FDA
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