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About CDER Small Business and Industry Assistance (SBIA)
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FDA
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A stronger role for EMA , , 31/01/2022
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293
EMA
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FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer
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309
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FDA approves pembrolizumab combination for the first-line treatment of cervical cancer
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269
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Advances in FDA's Drug Safety Programs
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239
FDA
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FDA approves abemaciclib with endocrine therapy for early breast cancer
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220
FDA
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FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia
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254
FDA
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FDA-ASCO Hematology and Oncology Fellows Day Workshop. - 11/16/2021
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240
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FDA approves ruxolitinib for chronic graft-versus-host disease
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239
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FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
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243
FDA
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FDA-EMA Parallel Scientific Advice (PSA) Program - 03/16/2022
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286
FDA
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Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil
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240
FDA
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Activities Report of the Generic Drugs Program (FY 2021) – FDARA Title VIII Section 807 and 805
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407
FDA
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Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
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230
FDA
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Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
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288
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Guidances (Drugs)
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323
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Laboratory Information Bulletins
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317
FDA
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Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
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284
FDA
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Postmarket Requirements and Commitments
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350
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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate M
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260
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