Info Obat dan Regulator Obat Dunia

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Dermatologic and Ophthalmic Drugs Advisory Committee Roster
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275
FDA
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Generic Competition and Drug Prices
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233
FDA
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Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
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542
FDA
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FDA draft guidance aims to improve consistency of labeling for nonprescription drugs
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264
FDA
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Registered Outsourcing Facilities
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277
FDA
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Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
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347
FDA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022, CVMP, 09/09/2022
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331
EMA
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2020 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
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215
FDA
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2019 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
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236
FDA
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Cardiovascular and Renal Drugs Advisory Committee Charter
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249
FDA
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2019 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee
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242
FDA
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2020 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee
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217
FDA
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General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products
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293
FDA
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Fluorouracil and Pet Safety
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249
FDA
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CDER and CBER accept first submission to ISTAND Pilot Program
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264
FDA
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Have your say on EMA’s communications – how are we doing?, , 01/09/2022
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429
EMA
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First adapted COVID-19 booster vaccines recommended for approval in the EU, CHMP, 01/09/2022
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283
EMA
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New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone, CHMP, 02/09/2022
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330
EMA
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PRAC starts review of topiramate use in pregnancy and women of childbearing potential, PRAC, 02/09/2022
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344
EMA
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Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan, , 30/08/2022
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253
EMA
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