Info Obat dan Regulator Obat Dunia

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Science & Research
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FDA Study Data Technical Conformance Guide - 11/27/2018
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236
FDA
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Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets
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282
FDA
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ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particul
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211
FDA
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Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosod
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278
FDA
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Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil
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303
FDA
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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 - 09/28/2023
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245
FDA
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Information about Naloxone and Nalmefene
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242
FDA
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FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product
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221
FDA
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CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
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224
FDA
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FDA Roundup: July 28, 2023
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265
FDA
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Transition from CFC Propelled Albuterol Inhalers to HFA Propelled Albuterol Inhalers: Questions and Answers
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275
FDA
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Kumar Organic Products Limited - 598683 - 04/23/2020
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255
Center for Drug Evaluation and Research
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Kumar Organic Products Limited - 598683 - 07/24/2023
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196
FDA
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CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)
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234
FDA
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Assessing User Fees Under the Biosimilar User Fee Amendments of 2022
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215
FDA
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CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)
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228
FDA
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Prescription Stimulant Medications
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237
FDA
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CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
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315
FDA
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FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosag
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229
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