Info Obat dan Regulator Obat Dunia

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Public consultation on reflection paper on prophylactic use of antimicrobials in animals, , 08/02/2022
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365
EMA
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EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents , CHMP, 08/02/2022
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300
EMA
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Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU, , 09/02/2022
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469
EMA
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PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market, PRAC, 11/02/2022
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327
EMA
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EMA starts safety review of Janus kinase inhibitors for inflammatory disorders, PRAC, 11/02/2022
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282
EMA
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022, PRAC, 11/02/2022
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342
EMA
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Inter-governmental Working Meeting on Drug Compounding, October 27-28, 2020
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304
FDA
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2021 First Generic Drug Approvals
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260
FDA
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Inter-governmental Working Meeting on Drug Compounding, October 26-27, 2021
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295
FDA
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Compounding Information for States
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273
FDA
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Tianeptine Products Linked to Serious Harm, Overdoses, Death
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274
FDA
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Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION Capsules Due to the Presence of Undeclared Tadalafil
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360
FDA
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OPDP News
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349
FDA
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Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee - 02/15/2022
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253
FDA
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The Brief Summary
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375
FDA
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FDA's Sentinel Initiative - Background
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327
FDA
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Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
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266
FDA
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Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology
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450
FDA
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Drug Product Tracing: The Effect of Section 585 of the FD&C Act instead of FDA’s guidance on uniform national policy
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500
FDA
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Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil
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350
FDA
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