Info Obat dan Regulator Obat Dunia

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News & Events for Human Drugs
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302
FDA
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Peripheral and Central Nervous System Drugs Advisory Committee Roster
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331
FDA
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Inspection of Injectable Products for Visible Particulates
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311
FDA
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Completed PDUFA VI Deliverables
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325
FDA
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International regulators stress continued need for COVID-19 therapeutics, , 10/12/2021
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301
EMA
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Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 December 2021, CVMP, 10/12/2021
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353
EMA
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Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
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344
FDA
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Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products
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288
FDA
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Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry
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361
FDA
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Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry
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311
FDA
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Medical Imaging Drugs Advisory Committee Roster
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363
FDA
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List of Determinations Including Written Request
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278
FDA
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Prescription to Over-the-Counter (OTC) Switch List
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371
FDA
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Efficient Laboratories, Inc. Expands Voluntary Nationwide Recall to Consumers to Include Twelve Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rom
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304
FDA
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
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367
FDA
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CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
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287
FDA
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Development of Anti-Infective Drug Products for the Pediatric Population
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293
FDA
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Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
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309
FDA
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How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product
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320
FDA
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Real-World Evidence
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378
FDA
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