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Endpoints News - FDA unveils 5 guidances on broadening cancer clinical trial eligibility

As part of a push to transform clinical trial eligibility criteria that have been accepted over time without a clear scientific or clinical rationale, the FDA on Tuesday published four draft guidance documents on cancer clinical trial eligibility criteria and one final guidance on including adolescents in adult oncology trials.


Targeted Oncology - Are Comorbid Conditions Excluding Otherwise Eligible Patients From Clinical Trial Enrollment?

The presence of comorbid conditions was associated with lower rates of clinical trial discussions between patients and their physicians, subsequently leading to decreased trial participation, according to an analysis performed by Southwest Oncology Group (SWOG).1


Barriers to clinical trial enrollment are multifaceted, and the decision by a patient to participate does not guarantee involvement. Physical barriers to participation, like limited access to a cancer clinic, may preclude a patient from accessing an appropriate clinical trial for their disease.


PharmExec - Administration Acts Fast to Smooth Transition to New FDA Commissioner

Health and Human Services (HHS) Secretary Alex Azar wasted little time in naming a new leader for FDA. Norman (Ned) Sharpless, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), will become acting commissioner next month as Scott Gottlieb departs the agency. The appointment won praise on all sides, as Sharpless is a respected cancer researcher and well-acquainted with FDA operations and challenges.


Reuters - National Cancer Institute chief to serve as acting FDA head

U.S. President Donald Trump’s administration has tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration, following the resignation of Scott Gottlieb earlier this month. Sharpless, who has led the National Institutes of Health’s cancer unit since 2017, will take over following Gottlieb’s exit in April, the U.S. Department of Health and Human Services said on Tuesday.


The New York Times - National Cancer Chief, Ned Sharpless, Named F.D.A.’s Acting Commissioner

Dr. Norman E. (Ned) Sharpless, director of the National Cancer Institute, will serve as acting commissioner of the Food and Drug Administration, Alex M. Azar III, secretary of health and human services, announced on Tuesday.


Dr. Sharpless temporarily will fill the post being vacated by Dr. Scott Gottlieb, who stunned public health experts, lawmakers and consumer groups last week when he abruptly announced that he was resigning for personal reasons.


CQ Roll Call - Cancer Institute Chief Will Lead FDA on Acting Basis

Norman E. “Ned” Sharpless, the current head of the National Cancer Institute at the National Institutes of Health, will serve as the acting Food and Drug Administration Commissioner when Scott Gottlieb steps down in April, Health and Human Services Secretary Alex Azar told lawmakers Tuesday.


The administration is still considering who to nominate as the permanent FDA commissioner, Azar told the Energy and Commerce Health Subcommittee during a hearing on the HHS fiscal 2020 budget proposal.


FierceBiotech - With NCI Director Sharpless in as interim FDA head, what does that mean for interagency cooperation?

It's official: NCI Director Ned Sharpless will take on the role of acting commissioner of the FDA. But what does the appointment mean for interagency cooperation between the federal government’s main medical research and innovation arm and its industry regulator?


Outgoing FDA Commissioner Scott Gottlieb, who is expected to step down in early April, tweeted his approval of the pick, writing: “Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”


Inside Health Policy - Azar Taps Nat’l Cancer Institute Director As Acting FDA Commissioner

National Cancer Institute Director Ned Sharpless will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).


Sharpless was among three candidates viewed as top contenders for the job, and Azar said Sharpless’ “deep scientific background and expertise will make him a strong leader for FDA,” he said.


Pink Sheet - New Acting US FDA Commissioner Shares Agency's Clinical Trial Reform Message

Executive Summary

Norman Sharpless, director of the National Cancer Institute, will become acting FDA commissioner when Scott Gottlieb departs.


The US FDA's incoming acting commissioner shares an enthusiasm for clinical trial system reform that should mesh well with the message many senior agency officials have been pushing for years.


The Washington Post - Nation’s cancer chief appointed acting FDA commissioner

National Cancer Institute Director Norman “Ned” Sharpless will become acting commissioner of the Food and Drug Administration, Health and Human Services Secretary Alex Azar said Tuesday.


Sharpless, 52, an accomplished researcher, oncologist and administrator, has been director of the cancer institute for about 18 months, earning good reviews from cancer advocates, patient groups and academic researchers. He will succeed Scott Gottlieb, who announced his resignation last week and with whom he has a cordial relationship. Gottlieb supported his appointment.