Searching Content indexed under Food and Drugs Law by Aaron L. Josephson ordered by Published Date Descending.
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Congress Looking To Streamline CBD Drug Research
We've previously blogged about the regulation of CBD by the Food and Drug Administration (FDA), and it appears that the dialogue around CBD
United States
16 Aug 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
Software Update: The Latest On FDA's Pre-Cert Pilot
Regular readers of this blog know that we're closely following the FDA's proposed regulatory framework for software as a medical device (SaMD), known as precertification
United States
26 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
FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent
Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI's Cosmetics & Personal Care Products conference on March 28, 2019.
United States
8 May 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
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
Paradigm Shift: Regulating Software As A Medical Device In The U.S.
Therefore, FDA believes SaMD is different enough from hardware devices to warrant a different regulatory model.
United States
28 Dec 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
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