February 20, 2024

Patient Labeling Resources

On this page Who is the audience for this webpage? FDA’s patient labeling specific resources on this webpage are primarily directed to industry staff who develop […]
February 20, 2024

CDER Data Standards Program

Each year, CDER receives more than 300,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market […]
February 20, 2024

Ongoing | Cancer Accelerated Approvals

Amtagvi (lifileucel) Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with […]
February 20, 2024

Verified Clinical Benefit | Cancer Accelerated Approvals

Tepmetko (tepotinib) Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. 2/3/2021 2/15/2024 Keytruda (pembrolizumab) Treatment […]
February 20, 2024

Division of Applied Regulatory Science

What We Do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]
February 20, 2024

Internet Pharmacy Warning Letters

Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal […]
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