Info Obat dan Regulator Obat Dunia

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Requesting a Pre-Assigned Application number
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266
FDA
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FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults
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247
FDA
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Gear Isle Issues Voluntary Nationwide Recall of Pro Power Knight Plus, NUX Male Enhancement and DYNAMITE SUPER Capsules Due to the Presence of Sildena
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199
FDA
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Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown
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199
FDA
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PDUFA VII Information Technology and Bioinformatics Goals and Progress
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334
FDA
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First vaccine to protect older adults from respiratory syncytial virus (RSV) infection, CHMP, 26/04/2023
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253
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023, CHMP, 26/04/2023
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255
EMA
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Nose Slap LLC - 654566 - 04/24/2023
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284
FDA
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Pharmaceutical Quality - Chemistry, Manufacturing & Controls (PQ/CMC)
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305
FDA
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FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
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257
FDA
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Accra-Pac, Inc. dba Voyant Beauty - 643600 - 04/20/2023
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219
FDA
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2023 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/0
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191
FDA
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"Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
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247
FDA
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Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. - 651522 - 04/19/2023
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271
FDA
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Epidemiologist Careers at CDER
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277
FDA
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European Immunization Week 2023: Statement by Executive Director Emer Cooke - Routine vaccination matters! Every dose counts to stay protected, , 24/0
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224
EMA
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EMA business hours over King's Day and Labour Day, 27 April and 1 May, , 25/04/2023
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219
EMA
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Regulatory Education for Industry (REdI) Annual Conference 2023 - 06/05/2023
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309
FDA
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Single-arm trials as pivotal evidence for the authorisation of medicines in the EU, , 21/04/2023
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308
EMA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023, CVMP, 21/04/2023
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277
EMA
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