Info Obat dan Regulator Obat Dunia

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FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
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257
FDA
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The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 - 12/07/2022
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310
FDA
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Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to
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294
FDA
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Shuzy Rock Inc. - 630110 - 09/01/2022
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296
FDA
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"David M. Lubeck, M.D./Arbor Centers for EyeCare - 643531 - 11/18/2022
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236
FDA
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2018 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)
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210
FDA
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2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)
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215
FDA
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Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions - 11/30/2022
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249
FDA
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Cadila Healthcare Limited - 584856 - 10/29/2019
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217
Center for Drug Evaluation and Research
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2019 Meeting Materials, Dermatologic and Ophthalmic Drugs Advisory Committee
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224
FDA
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Zydus Lifesciences Limited - 584856 - 11/03/2022
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307
FDA
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Guidance Webinar Series
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281
FDA
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Charging for Investigational Drugs Under an IND - Questions and Answers
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208
FDA
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DARWIN EU® welcomes first data partners, , 23/11/2022
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367
EMA
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Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis
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324
FDA
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FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulat
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385
FDA
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Rosebud's Ranch and Garden, LLC - 628567 - 10/18/2022
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250
FDA
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Drug Trial Snapshot: EVKEEZA
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234
FDA
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BeSafeRx: Resources for Consumers
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237
FDA
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New Quality Innovation Expert Group (QIG) supports medicine innovation, , 21/11/2022
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293
EMA
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