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Home Regulatory Agency Perspective

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

In Speech to Agency, New FDA Commissioner Highlights Anti-Smoking Efforts

on: August 01, 2017In: Regulatory Agency Perspective
In Speech to Agency, New FDA Commissioner Highlights Anti-Smoking Efforts

By Erik T. MacLaren, PhD On May 11, 2017, Scott Gottlieb, MD, was sworn in as the 23rd Commissioner of Food and Drugs of the US Food and Drug Administration […] Read more

NCI Corner – Interview with Matthew Holderfield, PhD

on: June 01, 2017In: Regulatory Agency Perspective
NCI Corner - Interview with Matthew Holderfield, PhD

Posted: June 2017 NCI to Team Up with Cancer Research UK and the Cancer Research Technology Pioneer Fund on RAS Research On April 19, 2017, Cancer Research UK (CRUK) and […] Read more

FDA Corner – Interview with Commander Jason Humbert

on: May 31, 2017In: Regulatory Agency Perspective
FDA Corner - Interview with Commander Jason Humbert

Posted: June 2017 FDA Warns of Fraudulent Cancer Drugs On April 25, 2017, the US Food and Drug Administration (FDA) issued warning letters to 14 companies regarding more than 65 […] Read more

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