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May 14, 2019
As Congress considers comprehensive reforms to the regulatory paradigm for all in vitro clinical tests (IVCTs), including LDTs, recent developments are highlighting the limitations of FDA’s current... Read more
May 13, 2019
The much-admired system to review grant proposals at the National Institutes of Health (NIH) in Bethesda, Maryland, has become the latest flashpoint in a long-running battle between Congress and the... Read more
May 9, 2019
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... Read more
May 7, 2019
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... Read more
April 26, 2019
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... Read more
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