News & Analysis as of

Proposed Regulation Life Sciences Regulatory Agenda

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

A&O Shearman

Commission proposal for a new European legal framework for GMOs

A&O Shearman on

In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more

Foley Hoag LLP

Harmonization Is Key: FDA’s Proposed Rule Seeks to Revamp Medical Device Quality System Regulation

Foley Hoag LLP on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more

Hogan Lovells

HHS tackles barriers to value-based care: Part two – Substantial Stark Law regulatory revisions proposed

Hogan Lovells on

Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more

Hogan Lovells

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

Hogan Lovells on

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more

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