What's New: Drugs RSS Feed · Scour

What's New: Drugs RSS Feed fda.gov

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

fda.gov·5h

GDUFA Type II API DMF Payment Receipts Report

fda.gov·20h

Generic Drug User Fee Amendments

fda.gov·21h

Bayesian Statistical Analysis (BSA) Demonstration Project

fda.gov·23h

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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GDUFA Paid Facilities List

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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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Newly Added Guidance Documents

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