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Home Regulatory Agency Perspective

In Brief for Dec. 21, 2022

Erin Jungmeyer
on: December 20, 2022In: Regulatory Agency Perspective, Society News
In Brief for Dec. 21, 2022

IASLC names J. Michael Hoehn COO. FDA approves adagrasib for KRAS G12C-mutated NSCLC. NHS England increases access to screening in effort to catch cancers earlier. Read more


In Brief for Dec. 7, 2022

Erin Jungmeyer
on: December 06, 2022In: Meeting News, Regulatory Agency Perspective
In Brief for Dec. 7, 2022

Learn how new guidance from the UK’s National Institutes for Health Care Excellence addresses an unmet clinical need for patients with EGFR+ NSCLC with exon 20 insertion and stay up to date on the latest meeting news from IASLC. Read more

Pembrolizumab Considered for Second Tissue-Agnostic Cancer Indication

on: August 20, 2020In: Regulatory Agency Perspective
Pembrolizumab Considered for Second Tissue-Agnostic Cancer Indication

By Erik MacLaren, PhD Posted: August 21, 2020 The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Merck’s immune checkpoint inhibitor pembrolizumab, adding a new tissue-agnostic indication […] Read more

New FDA Commissioner Confirmed

on: February 11, 2020In: Regulatory Agency Perspective
New FDA Commissioner Confirmed

Posted: February 12, 2020 December 12, 2019—Stephen M. Hahn, MD, FASTRO, was confirmed as commissioner of the U.S. Food and Drug Administration by a Senate vote of 72 to 18. […] Read more

Dr. Richard Pazdur Discusses Project Facilitate and the Expanded-Access Program

on: December 10, 2019In: Regulatory Agency Perspective
Dr. Richard Pazdur Discusses Project Facilitate and the Expanded-Access Program

Posted: December 11, 2019 In June 2019, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence launched Project Facilitate, a call center that assists oncology healthcare professionals with […] Read more

NCI Director Dr. Norman E. Sharpless Discusses 2019 Budget Plans During Social Media Event

on: April 05, 2019In: Regulatory Agency Perspective
NCI Director Dr. Norman E. Sharpless Discusses 2019 Budget Plans During Social Media Event

By Erik MacLaren, PhD Posted: April 1, 2019 On January 25, 2019, the Director of the National Cancer Institute (NCI) Norman E. Sharpless, MD, participated in a live social media event […] Read more

FDA Approval Processes in the Era of Targeted Therapies: A Conversation with Dr. Richard Pazdur

on: December 12, 2018In: Regulatory Agency Perspective
FDA Approval Processes in the Era of Targeted Therapies: A Conversation with Dr. Richard Pazdur

Posted: December 2018 Richard Pazdur, MD, is director of the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence. Below, he discusses the current status of and future directions […] Read more

NCI Corner: Racial Differences in the Transcriptomes of Lung Tumors

on: December 12, 2018In: Regulatory Agency Perspective
NCI Corner: Racial Differences in the Transcriptomes of Lung Tumors

Posted: December 2018 Investigators at the National Cancer Institute (NCI) compared the transcriptional profiles of lung cancers from African American patients to those from white patients and identified molecular differences […] Read more

NCI Selects Five Teams of Researchers to Expand Discovery of Predictive Biomarkers for Immunotherapy

on: August 27, 2018In: Regulatory Agency Perspective
NCI Selects Five Teams of Researchers to Expand Discovery of Predictive Biomarkers for Immunotherapy

Posted: August 2018 In October 2017, the United States National Cancer Institute (NCI) launched a major effort to expand the discovery and validation of predictive biomarkers on cancer immunotherapy. This […] Read more

The Budget Landscape with Dr. Douglas R. Lowy

on: August 27, 2018In: Regulatory Agency Perspective
The Budget Landscape with Dr. Douglas R. Lowy

By Erik MacLaren, PhD Posted: August 2018 The National Cancer Institute (NCI) and researchers who rely on the funding it provides have spent much of the past year under the […] Read more

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