Info Obat dan Regulator Obat Dunia

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Principles of Premarket Pathways for Combination Products
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257
FDA
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New EU rules for safe and high-quality medicines for animals become effective, , 28/01/2022
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312
EMA
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New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma, CHMP, 28/01/2022
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350
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022, CHMP, 28/01/2022
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323
EMA
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Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
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308
FDA
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Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination
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298
FDA
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Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination
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270
FDA
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COVID-19: EMA recommends conditional marketing authorisation for Paxlovid, PRAC, 27/01/2022
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274
EMA
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FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma
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271
FDA
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Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children
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246
FDA
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Aurobindo Pharmaceutical Limited - 618091 - 01/12/2022
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279
FDA
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CES LLC - 623495 - 01/18/2022
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277
FDA
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Health Plus Inc. - 616877 - 12/29/2021
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272
FDA
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Tips for Women to Prevent Heart Disease
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258
FDA
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Good ANDA Submission Practices Guidance for Industry
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285
FDA
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Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry
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294
FDA
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Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry
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348
FDA
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FDA issues series of guidances under Drug Competition Action Plan
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240
FDA
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Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System
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346
EMA
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Untitled Letters 2022
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370
FDA
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