Info Obat dan Regulator Obat Dunia

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FDA issues guidance on using remote oversight tools to help approve drugs
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FDA
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Allimax Us - 609328 - 01/12/2021
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219
Center for Food Safety and Applied Nutrition
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Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
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203
FDA
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Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
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219
FDA
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Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
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194
FDA
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Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
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233
FDA
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FDA Roundup: September 19, 2023
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212
FDA
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Maison Blanche LLC - 666943 - 09/14/2023
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254
FDA
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Drug Trials Snapshot: LYBALVI
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218
FDA
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Software Associated with Prescription Drugs: Opportunities to Enhance Safe and Effective Medication Use
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284
FDA
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CDER Creates New Biosimilars Resources for Educators, Teaching Facilities
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251
FDA
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FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules
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386
FDA
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FDA Roundup: September 15, 2023
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262
FDA
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Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)
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221
FDA
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Labeling for Biosimilar and Interchangeable Biosimilar Products
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202
FDA
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EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
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230
EMA
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EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna, CHMP, 15/09/2023
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230
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
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361
EMA
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Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 14/09/2023
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318
EMA
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Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
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328
EMA
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