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Home Regulatory Agency Perspective

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

FDA Fosters Understanding about Approval Process for Biosimilars

on: June 01, 2018In: Regulatory Agency Perspective
FDA Fosters Understanding about Approval Process for Biosimilars

By Leah Christl, PhD, Associate Director for Therapeutic Biologics and Director of the Therapeutic Biologics and Biosimilars Staff, Center for Drug Evaluation and Research, FDA Posted: June 2018 All FDA-approved […] Read more

The Upcoming Lung Cancer Neoadjuvant Meeting

on: February 19, 2018In: Regulatory Agency Perspective
The Upcoming Lung Cancer Neoadjuvant Meeting

(Photo: Gideon Blumenthal, MD, Nicole Drezner, MD, Mark G. Kris, MD) By Erik J. MacLaren, PhD Posted: February 2018 The development of immunotherapies and targeted therapies for use in lung cancers […] Read more

Discussing ALCHEMIST with Dr. Shakun Malik

on: December 18, 2017In: Regulatory Agency Perspective
Discussing ALCHEMIST with Dr. Shakun Malik

Posted: December 2017 Patients with completely resected early-stage non-small cell lung cancer (NSCLC) have approximately a 50% chance of experiencing disease recurrence following standard treatment. In 2014, the NCI initiated […] Read more

INFORMED: An Interview with Sean Khozin, MD, MPH

on: December 18, 2017In: Regulatory Agency Perspective
INFORMED: An Interview with Sean Khozin, MD, MPH

Posted: December 2017 The Information Exchange and Data Transformation (INFORMED) initiative was launched by the U.S. Food and Drug Administration (FDA) and the Innovation, Design, Entrepreneurship and Action (IDEA) Lab […] Read more

New Strategy for Tobacco Regulation

on: September 28, 2017In: Regulatory Agency Perspective
New Strategy for Tobacco Regulation

By Erik J. MacLaren, PhD Posted: October 2017 On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new, multi-year strategy intended to reduce tobacco-related disease and […] Read more

Tools for Smoking Cessation

on: September 28, 2017In: Regulatory Agency Perspective
Tools for Smoking Cessation

By Erik J. MacLaren, PhD Posted: October 2017 Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration, said in a recent speech, “There’s probably no single intervention or […] Read more

NCI Corner – Interview with Jeff Abrams

on: August 01, 2017In: Regulatory Agency Perspective
NCI Corner - Interview with Jeff Abrams

NCI Helping to Save Lives and Improve Cancer Survival Rates Scientific data from clinical trials are essential for evaluating new cancer treatments and setting new standards of care for patients. […] Read more

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