Info Obat dan Regulator Obat Dunia

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First gene therapy to treat severe haemophilia A, CHMP, 24/06/2022
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282
EMA
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022, CHMP, 24/06/2022
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327
EMA
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Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
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303
FDA
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Office of New Drugs (OND) | Annual Reports
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249
FDA
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Office of New Drugs (OND) | Annual Reports
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260
FDA
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Grimann S.A. de C.V. - 632272 - 06/03/2022
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280
FDA
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Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP - 05/16/2022
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298
FDA
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Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
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274
FDA
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Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
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442
FDA
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EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU, CHMP, 23/06/2022
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467
EMA
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EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, PDCO, 23/06/2022
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261
EMA
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AcelRx Pharmaceuticals, Inc. - 613257 - 02/11/2021
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255
FDA
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AcelRx Pharmaceuticals, Inc. - 613257 - 03/28/2022
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267
FDA
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Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
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371
FDA
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Considerations for Rescinding Breakthrough Therapy Designation
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232
FDA
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Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
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433
FDA
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eCTD Resources
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256
FDA
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Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
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262
FDA
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FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation
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284
FDA
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Accurate RX Pharmacy Consulting LLC dba Accurate Rx Pharmacy - 604449 - 09/02/2020
  • Division of Pharmaceutical Quality Operations III
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240
Division of Pharmaceutical Quality Operations III
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