Recently Issued Guidance Documents
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Over-the-Counter OTC | Nonprescription Drugs
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Untitled Letters
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Drug Trials Snapshots
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Drug Trials Snapshot: LYNOZYFIC
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Competitive Generic Therapy Approvals
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Novel Drug Approvals for 2025
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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
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Verified Clinical Benefit | Cancer Accelerated Approvals
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Ongoing | Cancer Accelerated Approvals
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GDUFA Type II API DMF Payment Receipts Report
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Generic Drug User Fee Amendments
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Bayesian Statistical Analysis (BSA) Demonstration Project
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What's New Related to Drugs
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Health Fraud Scams
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Oncology (Cancer)/Hematologic Malignancies Approval Notifications
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FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
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Radioactive Drug Research Committee (RDRC) Program
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What are the Qualifications and Requirements of RDRC Membership?
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What Information Does the RDRC Review?
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