In The News

September 22, 2021

NPR - The FDA Has Been Without A Permanent Leader For 8 Months As COVID Cases Climb

President Biden's failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it's baffling for the agency to…
Read more
September 21, 2021

Pink Sheet - Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

The US Food and Drug Administration is asking cancer drug sponsors to think about the studies intended to support accelerated approval, as well as those aimed at confirming clinical benefit…
Read more
September 21, 2021

Endpoints News - When efficacy is borderline: FDA needs to get more consistent on close-call drug approvals, agency-funded research finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a…
Read more
September 16, 2021

The New England Journal of Medicine - Treatment of Older Adults with Cancer — Addressing Gaps in Evidence

Eliminating inequities in health care is an important priority. One persistent inequity involves the lack of data to guide cancer care for older adults. Although clinical trials provide the strongest…
Read more
August 27, 2021

Regulatory Focus - Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials

While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments…
Read more
August 18, 2021

OncLive - 3 Precision Era Biomarkers Get a Closer Look

Circulating tumor DNA, tumor mutational burden, and homologous recombination deficiency are 3 emerging biomarkers for tailoring therapy need further clinical and technical clarity to support robust…
Read more
August 10, 2021

STAT News - Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?

WASHINGTON — For most of its history, the Food and Drug Administration’s shortcut pathway for approving certain medicines was hardly contentious among anyone but the most diehard agency nerds; for…
Read more
August 2, 2021

Pink Sheet - FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’

President Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H) might be able to provide the leadership necessary to cut across barriers between industry and government and within…
Read more
August 2, 2021

PharmExec.com - FDA’s Pazdur Challenges Attack on Accelerated Approval Program

In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, the agency’s leading cancer expert lashed…
Read more
July 30, 2021

Regulatory Focus - Pazdur mounts defense of accelerated approval during Cures 2.0 panel

During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the…
Read more