Info Obat dan Regulator Obat Dunia

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Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure
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317
FDA
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Regulatory Health Project Manager Jobs in CDER
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289
FDA
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FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
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266
FDA
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First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder, CHMP, 20/05/2022
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290
EMA
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Synchron Research Service: suspension of medicines over flawed studies, CHMP, 20/05/2022
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298
EMA
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First therapy to treat rare genetic nervous system disorder AADC deficiency, CHMP, 20/05/2022
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290
EMA
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First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes), CHMP, 20/05/2022
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273
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022, CHMP, 20/05/2022
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319
EMA
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Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules
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414
FDA
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Clinical Investigator Training Course (CITC) Update - 12/07/2021
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232
FDA
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SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination
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301
FDA
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Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
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341
FDA
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Frequently requested or proactively posted drug-specific and other records
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266
FDA
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Drug Supply Chain Security Act (DSCSA) Implementation Plan
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228
FDA
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Office of Prescription Drug Promotion (OPDP) Research
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253
FDA
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Risk Management Plans to Mitigate the Potential for Drug Shortages
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229
FDA
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FDA's “All-in” Approach to Enterprise Transformation
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434
FDA
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Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
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324
FDA
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CDER Takes Steps to End Prescription Pain Medicine Misuse, Abuse, and Addiction
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246
FDA
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Acetaminophen Information
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244
FDA
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