Info Obat dan Regulator Obat Dunia

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Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Indus
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239
FDA
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EMA business hours over Easter holiday, , 12/04/2022
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221
EMA
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EMA and the EUnetHTA 21 consortium set priorities for their collaboration , , 12/04/2022
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264
EMA
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I. Shay Cosmetics Inc - 552754 - 10/29/2018
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305
Center for Drug Evaluation and Research
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I. Shay Cosmetics Inc - 552754 - 12/29/2021
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278
FDA
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E8(R1) General Considerations for Clinical Studies
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246
FDA
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Anna Health, LLC - 613294 - 03/16/2021
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223
FDA
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CofixRx, LLC - 626860 - 04/05/2022
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262
FDA
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Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
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225
FDA
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022, PRAC, 08/04/2022
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295
EMA
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US-Canada Regional ICH Consultation - 05/11/2022
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332
FDA
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eCTD Important Notices
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275
FDA
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OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings - 03/29/2022
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246
FDA
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ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines, , 06/04/2022
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240
EMA
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA - 02/24/2022
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245
FDA
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Podcast: FDA’s Quality Metrics Reporting Program and the voluntary submission of Quality Metrics Data
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502
FDA
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CDER Quality Management Maturity
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267
FDA
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The ABCs of Product Specific Guidances
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257
FDA
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Honey Feast, Inc. - 621651 - 03/17/2022
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265
FDA
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NDAL Mfg Inc. - 621656 - 03/28/2022
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Views
305
FDA
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