Info Obat dan Regulator Obat Dunia

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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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Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022)
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230
FDA
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Generic Drugs Program Monthly and Quarterly Activities Report
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220
FDA
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Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
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206
FDA
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FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
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233
FDA
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Field Science - Laboratory Manual
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265
FDA
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Medical Countermeasure Monitoring and Assessment
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274
FDA
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Review and Approval
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300
FDA
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Protect Your Family From Fraudulent Flu Products
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357
FDA
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Overview for Health Care Professionals
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319
FDA
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Basics for Patients
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233
FDA
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Efficacy of Monoclonal Antibodies in the Context of Rapidly Evolving SARS-CoV-2 Variants - 12/15/2022
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235
FDA
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eCTD Submission Standards for eCTD v3.2.2 and Regional M1
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220
FDA
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Accelerating Rare disease Cures (ARC) Program
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232
FDA
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Biosimilars
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239
FDA
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Pulmonary Tuberculosis: Developing Drugs for Treatment
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220
FDA
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ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies, , 08/12/2022
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234
EMA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022, CVMP, 09/12/2022
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459
EMA
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ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2 , , 09/12/2022
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256
EMA
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Scientific Public Private Partnerships and Consortia
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228
FDA
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