Info Obat dan Regulator Obat Dunia

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Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
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269
FDA
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Conducting Remote Regulatory Assessments Questions and Answers
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0
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263
FDA
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Proposed Rule on Revising the National Drug Code Format
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302
FDA
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Real-Time Oncology Review (RTOR)
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0
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319
FDA
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Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)
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0
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334
FDA
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FDA Roundup: July 22, 2022
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280
FDA
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Public Notification: Lipopastilla + Gold Max contains hidden drug ingredients
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373
FDA
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Want to Quit Smoking? FDA-Approved and FDA-Cleared Cessation Products Can Help
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0
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272
FDA
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Voluntary Recall of Certain Over-the-Counter Products
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0
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343
FDA
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Public Notification: Burn 7 contains hidden drug ingredient
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0
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314
FDA
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2022 PDA/ FDA Joint Regulatory Conference - 09/12/2022
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225
FDA
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Meetings, Conferences, & Workshops | Drugs
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327
FDA
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FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs - 09/19/2022
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283
FDA
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Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
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0
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460
FDA
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Evaluation of Therapeutic Equivalence
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0
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281
FDA
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Q&A with FDA
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393
FDA
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Conversation on Paxlovid
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271
FDA
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CDER Conversation: CDER’s Drug Quality Sampling and Testing program
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432
FDA
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E
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022, CVMP, 15/07/2022
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0
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294
EMA
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C
Signa SA de CV - 605219 - 07/14/2020
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351
Center for Drug Evaluation and Research
C
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