Info Obat dan Regulator Obat Dunia

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Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
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261
FDA
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Start of rolling review for adapted Comirnaty COVID-19 vaccine, CHMP, 15/06/2022
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376
EMA
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Q9(R1) Quality Risk Management
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344
FDA
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Smitha C. Reddy, M.D./ACRC Studies, LLC - 634702 - 05/27/2022
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261
FDA
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Equine Podiatry Solutions, LLC - 633259 - 05/16/2022
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253
FDA
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Hybrid Pharma, LLC - 629021 - 06/07/2022
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278
FDA
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Remarks by Commissioner Califf to the 2022 FDLI Annual Conference - 06/14/2022
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254
FDA
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Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask - 06/30
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270
FDA
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Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collec
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318
FDA
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Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and De
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312
FDA
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Endocrinologic and Metabolic Drugs Advisory Committee Roster
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266
FDA
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Big Data strategy for veterinary medicines in the EU , , 13/06/2022
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241
EMA
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EMA publishes annual report 2021, , 10/06/2022
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251
EMA
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EMA recommends withdrawal of marketing authorisation for amfepramone medicines, PRAC, 10/06/2022
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282
EMA
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022, PRAC, 10/06/2022
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304
EMA
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Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination
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276
FDA
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Division of Hematologic Malignancies 1 (DHM1)
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265
FDA
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Ummzy LLC Issues Voluntary Nationwide Recall of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night Due to the Presence of Undeclared Tadalafil Sil
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233
FDA
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Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring
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317
FDA
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FAQs: What happens to EUAs when a public health emergency ends?
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259
FDA
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