Inside the Black Box

CNS Cancers

Approval of Dinutuximab for High-Risk Neuroblastoma: Lessons Learned in Expediting the Development of Pediatric Cancer Drugs

The ASCO Post  / December 10, 2016

On March 10, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to dinutuximab (formerly known as chimeric 14.18 antibody; Unituxin) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (retino...

Health-Care Policy

Oncology Drug Approvals: Year in Review

Richard Pazdur, MD  / February 25, 2016

In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities. The most notable were drug approvals in disease areas such as non–small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to tre...

Issues in Oncology

Development and Approval of Biosimilar Products

Leah Christl, PhD, and Albert Deisseroth, MD, PhD  / March 25, 2015

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director f...

Issues in Oncology

Pharmacokinetics and Exposure Response in Drug Development

Julie Bullock, PharmD, and Nitin Mehrotra, PhD  / February 25, 2015

INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how pharmacokineti...

Issues in Oncology

Top 10 Myths About FDA’s Office of Hematology and Oncology Products

Gideon Blumenthal, MD, and Tatiana Prowell, MD  / January 25, 2015

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...

Hematologic Malignancies
Solid Tumors
Issues in Oncology

Top 10 Myths About FDA’s Office of Hematology and Oncology Products

Gideon Blumenthal, MD, and Tatiana Prowell, MD  / November 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...

Lung Cancer

FDA Approval of Ceritinib for the Treatment of ALK-Positive Non–Small Cell Lung Cancer

The ASCO Post  / August 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Sean Khozin, MD, MPH, and Dikran Kazandjian, MD, discuss anaplastic lymphoma kinase (ALK)-positive non–small cell lung...

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