A recent White House oversight policy change could gum up the FDA’s day-to-day work and hurt industry’s ability to stay in compliance, lawyers told Bloomberg Law. A White House memo released this month concluded the Congressional Review Act gives more discretion to its Office of Management and Budget over regulatory agencies than previously thought.…
Last week the White House released a memo, which put forth a directive that potentially threatens the future of many scientific innovations that could save patients’ lives. The memo outlined that the Office of Management and Budget (OMB) would now need to review all non-binding guidance documents from all federal agencies. These guidance documents would…
The number of electronic health record systems joining with CancerLinQ to facilitate information sharing continues to grow. CancerLinQ LLC, a wholly owned nonprofit subsidiary of the American Society of Clinical Oncology, announced Varian’s ARIA Oncology Information System is the next Electronic Health Record System to be certified by CancerLinQ after meeting criteria for interoperability and…
Executive Summary Our infographic details organizational structure and management of FDA’s first inter-center institute; five of 11 associate director positions are being filled on an acting basis. The US FDA Oncology Center of Excellence’s (OCE) organizational structure reflects the cross-cutting nature of the two-year old office established to expedite the development and clinical evaluation…
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance regarding cancer trial eligibility criteria. VENTANA PD-L1 (SP142) Assay Approved as Companion…
President Donald Trump has proposed to cut $4.7 billion from the NIH budget, with almost $900 million coming out of NCI during the fiscal year 2020. According to the White House’s proposal, “A Budget for a Better America: Promises Kept. Taxpayers First.” released March 11, NIH would lose 12 percent and NCI, 15 percent.…
The newly named acting commissioner of the Food and Drug Administration (FDA) is poised to take over at a crucial time for the agency, as outgoing Commissioner Scott Gottlieb leaves an ambitious legacy largely unfinished. President Trump’s decision to tap Norman Sharpless as acting commissioner of the FDA is drawing praise from health advocates,…
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. The four drafts, developed…
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…
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.…
