Info Obat dan Regulator Obat Dunia

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How to Safely Use Glucose Meters and Test Strips for Diabetes
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276
FDA
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Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
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293
FDA
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FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritone
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438
FDA
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Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards - 01/13/2023
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354
FDA
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Drug Trials Snapshot: TEPMETKO
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260
FDA
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Resources for Information | Approved Drugs
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318
FDA
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EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders, CHMP, 11/11/2022
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247
EMA
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EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines, , 11/11/2022
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259
EMA
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New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome, CMDh, 11/11/2022
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299
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022, CHMP, 11/11/2022
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284
EMA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022, CVMP, 11/11/2022
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2K
EMA
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EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine, CHMP, 10/11/2022
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256
EMA
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FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer
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247
FDA
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FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma
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286
FDA
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Public Notification: Sangter Natural Male Energy Supplement contains hidden drug ingredient
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308
FDA
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Individual Patient Expanded Access Applications: Form FDA 3926
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225
FDA
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Sameness Evaluations in an ANDA — Active Ingredients
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390
FDA
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FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer
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257
FDA
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The Anthos Group, Inc. - 636846 - 11/03/2022
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339
FDA
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Abraxis Bioscience LLC - 633713 - 10/31/2022
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249
FDA
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