publication date: Dec. 5, 2014
20141205 - Dec. 5, 2014
ISSUE 45 – DEC. 5, 2014PDF

Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use.

Top NCI Officials Pledge No Further Consolidation of Clinical Trials System

Top NCI officials made an unusual assurance that the reorganization of clinical trials cooperative groups isn’t a “prelude to reducing the commitment of the NCI to clinical trials-based research.”

The document, published as a letter to the editor of the Journal of Clinical Oncology on Dec. 1, follows up on a meeting Sept. 23, where group chairs and directors of statistical centers asked NCI to assure them that no new cuts are in the works.

Brigham & Women’s Suspends Controversial Morcellation Study As Apparent “Difference of Opinion” with FDA Comes to Light

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery.

Launched earlier this summer, the study was designed to enroll 400 women to test dye leakage in several commercially available bags that have not been cleared by FDA for use with power morcellators.

Varmus’s 2016 Bypass Budget Seeks “Modest” Increase of $823 Million

NCI has published the bypass budget for the fiscal year 2016, asking for $5.754 billion, an $823 million increase over the estimated budget of $4.931 billion.

NYC Doctor Pays $2.35 Million To Settle False Claims Act Suit Over Radiosurgery Reimbursements

A New York City radiation oncologist who specializes in fractionated stereotactic radiosurgery and stereotactic body radiation therapy agreed to pay $2.35 million to resolve a 10-year-old Medicare fraud lawsuit.

 

Drugs and Targets

  • Blincyto granted accelerated approval in R/R ALL
  • Broad Institute, Harvard University, MIT and Editas Medicine form collaboration
  • FDA grants clearance to IQQA-BodyImaging
  • CMS issues final payment decision for Cologuard screening test
photoIn Brief

  • David Chambers named deputy director for implementation science at NCI DCCPS

  • Linda Weiss announces intention to retire from NCI Office of Cancer Centers

  • 2014 John Scott Award winners announced

  • Nicholas Petrelli receives clinical research award from the Association of Community Cancer Centers

  • Anjen Chenn named VP of clinical operations at Metamark

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