Info Obat dan Regulator Obat Dunia

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Plan B One-Step (1.5 mg levonorgestrel) Information
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288
FDA
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Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use - 02/01/2023
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384
FDA
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M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
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225
FDA
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FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs
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245
FDA
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Contact OPDP
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280
FDA
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Facilitating Decentralised Clinical Trials in the EU , , 19/12/2022
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228
EMA
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End-of-year message from EMA’s Executive Director, , 21/12/2022
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349
EMA
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EMA business hours over holiday period, , 20/12/2022
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209
EMA
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M11 Clinical Electronic Structured Harmonised Protocol
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266
FDA
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Accelerated Approval Program
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232
FDA
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Other | Cancer Accelerated Approvals
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301
FDA
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Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impu
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266
FDA
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FDA Patient Listening Sessions
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260
FDA
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April - June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
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215
FDA
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FDA Approves New HIV Drug for Adults with Limited Treatment Options
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273
FDA
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An update on sunscreen requirements: The deemed final order and the proposed order
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251
FDA
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Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R
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253
FDA
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FDA approves imaging drug to help identify lung cancer lesions
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246
FDA
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EMA Management Board: highlights of December 2022 meeting, MB, 16/12/2022
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251
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022, CHMP, 16/12/2022
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325
EMA
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