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Regulatory Agenda Proposed Regulation Food and Drug Administration (FDA)

Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Holland & Knight LLP on

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

McDermott Will & Schulte

2024 Chart of Additional Healthcare Regulations

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

McDermott Will & Schulte

Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more

Perkins Coie

New Animal Feed Proposal Introduced in US House

Perkins Coie on

On December 7, U.S. Representative Greg Pence (R-IN) introduced the Innovative Feed Enhancement and Economic Development Act of 2023 (the Innovative FEED Act). Sen. Roger Marshall (R-KS) introduced the Senate version of the...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

McDermott+ on

The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - May 2023 #2

LEGISLATION, REGULATIONS & STANDARDS - Group Petitions USDA to Prohibit ‘Low-Carbon Beef’ Label, Require Verification for Carbon Claims - The Environmental Working Group (EWG) has petitioned the U.S. Department of...more

Perkins Coie

Proposed Bans on Five Food Additives Pending in California and New York

Perkins Coie on

Legislators in California and New York have proposed bills to ban five food additives that have purportedly been linked to health concerns such as cancer, neurodevelopmental issues, and hormone dysfunction. The five...more

Butler Snow LLP

Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

Butler Snow LLP on

Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...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

Mounting pressure at both federal and state levels to expand PFAS oversight in food packaging

Hogan Lovells on

California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer,...more

Hogan Lovells

FDA delays draft rule for QSR/ISO 13485 harmonization

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020. This is the second delay in the agency's...more

Seyfarth Shaw LLP

Cosmetics, Hemp, and CBD: Legislative and Regulatory Update

Seyfarth Shaw LLP on

Seyfarth Synopsis: Through a reintroduced House bill, Congress is taking strides to push for cosmetic regulation reform and, separately, through the SAFE Act, it is seeking to establish a safe harbor for financial...more

Mintz - Health Care Viewpoints

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 to retool oversight of laboratory...more

Mintz - Health Care Viewpoints

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. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed...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

Wilson Sonsini Goodrich & Rosati

Highlights and Commentary from the FDA's Public Workshop on Proposed Framework for Regulatory Oversight of Laboratory Developed...

On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more

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