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Pink Sheet - “Nobody Was Armed At NCI”: US FDA Head Sharpless Adjusts To Life As Regulator

Executive Summary

Acting commissioner is entering the usual learning curve for new leaders of the agency. It’s a reminder of how unusual it was to skip that step under his predecessor.


After one month on the job, acting US FDA Commissioner Ned Sharpless is starting to take on a higher public profile.


Inside Health Policy - Patients, Test Makers Ask Lawmakers To Meet On Diagnostics Bill Draft

Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices.


BioCentury - Patient access pitfalls, regulatory inconsistencies hamper tissue agnostic drugs

At a Friday meeting FDA co-hosted with ASCO and Friends of Cancer Research, patient advocates expressed concern over their ability to access newly approved tissue-agnostic medicines, as well as clinical trials assessing up-and-coming treatments based on molecular markers rather than tissue of origin. Stakeholders also raised concerns about the lack of access to tumor-profiling technologies and inconsistent approaches among regulators to tissue-agnostic drug development.


Bloomberg Law - Expanded White House Policy Could Stifle FDA’s Industry Advice

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. The statute outlines what sorts of agency rules and documents are subject to executive branch oversight.


The Hill - We are cutting government regulation at the expense of patients' lives

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 then be subject to a congressional vote. Guidances are intended to convey an agencies position on processes, policies and emerging questions of the field in which a specific agency regulates.

The Cancer Letter - Varian ARIA Oncology Information System awarded CancerLinQ certification

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 data standardization. This collaboration aims to dismantle barriers to information sharing and streamline access to CancerLinQ for oncology practices using Varian ARIA OIS.


Pink Sheet - Oncology Center Of Excellence Comes Of Age at US FDA

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 of drugs, biologics and medical devices intended to treat, diagnose or cure cancer.


The Cancer Letter - Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent

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.


If Trump’s budget request is enacted, the NIH budget would shrink from $39.1 billion in FY19 to $34.4 billion in FY20. The NCI budget would be slashed to $5.2 billion, down from $6.1 billion.


The ASCO Post - FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More

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.

The Hill - FDA faces test under new chief

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, who see it as an opportunity for the agency to continue its work uninterrupted.