18:10 , May 2, 2019 |  BioCentury  |  Politics, Policy & Law

Gottlieb: How a cultural shift is transforming FDA’s drug reviews

A decade ago, the FDA secured new tools, resources, and authorities to implement a watershed change in how the agency approached the drug review process. The novel framework turned on a more active approach to...
18:25 , Apr 19, 2019 |  BioCentury  |  Politics, Policy & Law

New White House policy could throttle FDA guidance-writing

A new Trump administration policy could slow the release of FDA guidance documents to a crawl, reducing transparency that product developers, patients and investors value. The policy is spelled out in an April 11 memo...
22:49 , Apr 8, 2019 |  BC Extra  |  Politics & Policy

CMS demo could pave the path to eliminating Part D rebates

The Trump administration is laying the groundwork to put policies in place in 2020 that would reduce out-of-pocket spending by senior citizens with high drug costs, boost drug company revenues -- and shift undetermined costs...
17:03 , Apr 8, 2019 |  BC Extra  |  Politics & Policy

Reps. Jordan, Meadows accuse Cummings of 'partisan' drug pricing investigation

Two House Republicans have accused Rep. Elijah Cummings (D-Md.) of leading a partisan investigation into drug pricing, and implied he could leak biopharmas' sensitive, proprietary information. In letters sent to 12 biopharmas, Reps. Jim Jordan...
17:08 , Apr 2, 2019 |  BC Extra  |  Politics & Policy

Bioinformatics pioneer Abernethy named FDA’s acting CIO

Principal Deputy FDA Commissioner Amy Abernethy will add acting chief information officer to her responsibilities, FDA announced Tuesday. She will lead the Office of Information Management and Technology. Abernathy, who joined FDA from Flatiron Health...
18:29 , Mar 21, 2019 |  BC Extra  |  Politics & Policy

New FDA biosimilars office, flatter Office of Commissioner finalized

When Ned Sharpless arrives at FDA headquarters as acting commissioner on April 8, his name will be placed at the top of an organizational chart that looks very different from the structure that was in...
01:35 , Mar 9, 2019 |  BioCentury  |  Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...
00:50 , Jan 15, 2019 |  BC Extra  |  Politics & Policy

MSKCC says senior execs may not hold industry board seats

Memorial Sloan Kettering Cancer Center has barred its senior executive officers from holding board positions at MSKCC spinouts or external for-profit health and science-related entities, according to a staff memo sent by SVP and Chief...
19:41 , Jan 9, 2019 |  BC Extra  |  Company News

Senior FDA official to head government affairs at CRISPR Therapeutics

John Martin, principal associate commissioner for legislative affairs at FDA, is leaving the agency and joining CRISPR Therapeutics AG (NASDAQ:CRSP) as head of government affairs. Martin, who joined FDA in 2017, led the agency's negotiation...
21:18 , Oct 22, 2018 |  BC Extra  |  Politics & Policy

FDA advisory committee to consider CV studies for diabetes drugs

FDA will ask an advisory committee this week to consider whether cardiovascular outcomes trial requirements for diabetes drugs should be diminished or discarded, according to draft questions released ahead of the Oct. 24-25 meeting. Intensified...