Searching Content indexed under Healthcare by Aaron L. Josephson ordered by Published Date Descending.
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ML Strategies Health Care Preview: Government Shutdown Looming?
Congress returns to session this week with days to pass a continuing resolution (CR) to keep the government open
United States
7 Oct 2019
ML Strategies Health Care Preview - Week Of July 29, 2019
This week, the Senate is expected to consider the House-passed two-year budget deal that will also suspend the debt limit for two years.
United States
2 Aug 2019
ML Strategies Health Care Preview - Week Of July 15, 2019
This week, the House is scheduled to vote on a repeal of the Cadillac tax, which is a forty percent tax on high-cost health plans.
United States
24 Jul 2019
ML Strategies Health Care Preview - Week Of May 20, 2019
This week, the House Energy & Commerce Committee is voting on seven more drug pricing bills. The Senate is going to be unveiling its cost-containment package in the coming weeks ...
United States
4 Jun 2019
Ml Strategies Health Care Preview: Congress's Summer Plans Filling Up Fast
This week, all is quiet in the Senate as stakeholders await the release of the highly anticipated cost-containment package ...
United States
31 May 2019
ML Strategies Health Care Preview Week Of April 29, 2019
Welcome back. This week will focus largely on "Medicare for All" proposals. The House Rules Committee will hold the first hearing on the subject this Congress
United States
15 May 2019
ML Strategies Health Care Preview - Week Of March 25, 2019
This week, House Democrats will unveil a sweeping health care bill aimed at lowering premiums and out-of-pocket costs, and to target actions taken ...
United States
5 Apr 2019
Device Modernization Series: In Vitro Clinical Tests
In our first two Device Modernization series posts, we discussed FDA's 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts
United States
18 Mar 2019
Device Modernization Series: FDA's Proposed De Novo Regulation
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program.
United States
8 Mar 2019
What To Expect At FDA Following Commissioner Gottlieb's Departure
On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, ​for whom this was ​a second stint at the FDA, intends to leave the agency in about a month to spend more time with his family.
United States
7 Mar 2019
Device Modernization Series: FDA's Changes To The 510(k) Program
In our "FDA 2018 Year in Review (and a Few Thoughts on 2019)" post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program
United States
28 Feb 2019
FDA 2018 Year In Review (And A Few Thoughts On 2019)
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018.
United States
4 Jan 2019
Medical Products & FDA: What To Watch For In 2019
Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years.
United States
10 Dec 2018
FDA's Refreshed Approach To Device Safety Would Require Major Changes To 510(K) Program
On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety.
United States
30 Nov 2018
Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities
On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year.
United States
26 Oct 2018
Strategies To Unlock AI's Potential In Health Care, Part 2: FDA's Approach To Protecting Patients & Promoting Innovation
Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers?
United States
19 Oct 2018
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