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Showing 17 - 24 of 480 results
The Buzz About Block Grants
January 16, 2019|Blog
ML Strategies Health Care Preview - January 14, 2019
January 15, 2019|Blog
ML Strategies Health Care Preview - Week of January 7, 2019
January 7, 2019|Blog
Transportation & Infrastructure in the 116th Congress
December 17, 2018|Advisory
ML Strategies Weekly Preview - December 17, 2018
December 17, 2018|Blog
What's Next After the Texas vs. Azar Ruling?
December 17, 2018|Blog
Summary of the IMPROVE Act
December 14, 2018|Blog
News & Press Releases
FDA Accepts Feedback On VALID, Clinical Lab Test Lobby Encouraged
March 28, 2019 | Inside Healthy Policy
This article explores American Clinical Laboratory Association (ACLA) president and CEO Julie Khani’s desire to start a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics. Specifically, she hopes to work with the agency on revisions to the bill's provision involving precertification and modification of existing tests in order to make those concepts less burdensome for test makers. Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, is among the industry sources quoted within the piece.
Device Experts: Pre-Cert, 510(k) Reforms Unaffected By Gottlieb Departure
March 9, 2019 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing how the FDA’s big-ticket medical device reform initiatives, such as medical software precertification, 510(k) predicate reform and changes to the de novo process likely will continue to develop as planned even as FDA Commissioner Scott Gottlieb, who has drawn attention to such efforts throughout his two-year tenure as agency chief, is due to resign in one month.
Former FDA Advisor: Abernethy Could Be Next In Line To Lead FDA
March 7, 2019 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing the possibility of FDA Principal Deputy Commissioner Amy Abernethy filling in as acting FDA commissioner, or possibly even succeed FDA Commissioner Scott Gottlieb when the current commissioner leaves the agency in a month.
Events
Apr
24
2019
16th Annual Medical Device Quality Congress
Bethesda, MD
May
2
2019