Info Obat dan Regulator Obat Dunia

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Project Orbis
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263
FDA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023, CHMP, 27/01/2023
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302
EMA
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EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair, CAT, 26/01/2023
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252
EMA
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EMA update on shortages of antibiotics in the EU, , 26/01/2023
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239
EMA
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Quarterly Inactive Ingredient Database (IID) Change Log
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218
FDA
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Data Standards Catalog v9.0
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238
FDA
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FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
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273
FDA
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Laboratoires Clarins - 568157 - 01/23/2023
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268
FDA
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Laboratoires Clarins - 568157 - 04/23/2019
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217
Center for Drug Evaluation and Research
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Mpox: Development of Drugs and Biological Products; Guidance for Industry
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232
FDA
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Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
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317
FDA
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Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
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218
FDA
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Leaf of Life LLC - 619191 - 08/04/2022
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269
FDA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023, CVMP, 20/01/2023
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309
EMA
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Assessment of human dietary exposure to residues of veterinary medicines in the EU, CVMP, 19/01/2023
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221
EMA
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Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines , , 20/01/2023
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262
EMA
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Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications, , 19/01/2023
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299
EMA
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Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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242
FDA
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Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
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291
FDA
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Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Dru
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249
FDA
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