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April 25, 2019
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... Read more
April 17, 2019
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... Read more
April 5, 2019
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... Read more
April 2, 2019
The news of Fred Malek's passing this past week left many in Washington, and across the country, to reflect - not only on the life of a giant of politics - but on what it means to be a philanthropist... Read more
April 1, 2019
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... Read more
March 15, 2019
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... Read more
March 15, 2019
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... Read more
March 14, 2019
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... Read more
March 13, 2019
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that have been accepted over time without a clear scientific or clinical rationale, the FDA on Tuesday published four draft guidance... Read more
March 13, 2019
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... Read more