Info Obat dan Regulator Obat Dunia

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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 2023, CVMP, 08/09/2023
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251
EMA
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FDA Roundup: September 8 2023
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238
FDA
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Clinical Pharmacology Considerations for Peptide Drug Products
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189
FDA
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Endogenous Cushing’s Syndrome: Developing Drugs for Treatment
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307
FDA
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Understanding FDA Inspections and Data - 09/06/2023
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331
FDA
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Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on Amazon Between May 31 an
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182
FDA
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FDA’s ‘Bad Ad’ Program Encourages HCPs to Report False or Misleading Prescription Drug Promotion
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320
FDA
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WEFUN Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil
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293
FDA
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Green Pharmaceutical Co. Ltd. - 663544 - 08/23/2023
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0
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218
FDA
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Lex Inc. - 656056 - 08/17/2023
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0
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268
FDA
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Osmosis, LLC - 652059 - 08/23/2023
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261
FDA
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Tainted Sexual Enhancement and Energy Products
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0
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271
FDA
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DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
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190
FDA
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023, PRAC, 01/09/2023
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267
EMA
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PRAC recommends new measures to avoid topiramate exposure in pregnancy, PRAC, 01/09/2023
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286
EMA
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Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment
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311
FDA
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Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up
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0
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259
FDA
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An Update on FDA’s Overdose Prevention Framework - Addressing Critical Areas of Need
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319
FDA
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Tapee Tea contains hidden drug ingredients
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299
FDA
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Post-Warning Letter Meetings Under GDUFA
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215
FDA
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