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Proposed Legislation Food and Drug Administration (FDA)

Knobbe Martens

Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”

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On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more

Alston & Bird

Look Ahead to the Week of July 22: Congress Returns as 2024 Election Takes Center Stage

Alston & Bird on

Both the House and Senate are back for two weeks before departing for August recess. Last week, Republicans rallied support for the nomination of former President Donald Trump and his running mate, JD Vance, at the Republican...more

McDermott Will & Emery

FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance

McDermott Will & Emery on

On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Foley Hoag LLP

States Wade into FDA Regulatory Territory to Address Chemicals in Foods and Personal Care Products

Foley Hoag LLP on

Increased public health interest in “forever chemicals” is leading to a new, complex regulatory landscape for manufacturers, distributors, and retailers of foods, cosmetics, and other consumer products. As FDA and other...more

Holland & Knight LLP

Holland & Knight Health Dose: June 11, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include:...more

Mintz - Health Care Viewpoints

National Academics of Science, Engineering, and Medicine Issues Report on Inclusion of Pregnant and Lactating Persons in Clinical...

Last month, the National Academies of Science, Engineering, and Medicine (“NASEM”) issued a report discussing the inclusion of pregnant and lactating people in clinical research and the health impacts of inadequate data from...more

McDermott Will & Emery

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Bradley Arant Boult Cummings LLP

Legalizing LSD? FDA Says Mm-hmm to MM120

If you know either of us, you know neither of us would pass up a chance to say, “I told you so.” As we looked ahead to 2024 in January, we speculated that psychedelics could be legalized as a prescription medicine. Now, not...more

BCLP

PFAS in Food Packaging: State-by-state Regulations - March 2024 (Update)

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In the absence of comprehensive federal regulation of PFAS in food packaging, states are dishing out their own laws. Thus far, twelve states have enacted laws addressing PFAS substances in food containers and packaging...more

BCLP

PFAS in Food Packaging: State-by-state Regulations - Updated March 2024

BCLP on

In the absence of comprehensive federal regulation of PFAS in food packaging, states are dishing out their own laws. Thus far, twelve states have enacted laws addressing PFAS substances in food containers and packaging...more

Alston & Bird

Look Ahead to the Week of March 4: The State of the Union and Government Spending

Alston & Bird on

Look Ahead to the Week of March 4: The State of the Union and Government Spending - Both the Senate and House are in session. This week, Congress will attempt to pass the first tranche of government spending bills after...more

Perkins Coie

New Pet Food Proposal Introduced in US House

Perkins Coie on

On February 15, a bipartisan group of five Congressional Representatives introduced the Pet Food Uniform Regulatory Reform Act of 2024 (the PURR Act) in the U.S. House. Currently, the FDA’s regulation of pet foods is...more

Troutman Pepper

More States Consider Establishing Vapor Product Directories

Troutman Pepper on

We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more

Holland & Knight LLP

Holland & Knight Health Dose: February 6, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Troutman Pepper

Multiple States Consider Establishing Vapor Product Directories

Troutman Pepper on

This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

Mintz - ML Strategies on

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Davis Wright Tremaine LLP

Real MEAT Act Reintroduced in Congress

Sen. Deb Fischer (R-Neb.), a cattle rancher and member of the Senate Agriculture Committee, thinks alternative protein products deceive Americans by imitating real meat. To address this issue, she has reintroduced the Real...more

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

ArentFox Schiff

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

McGlinchey Stafford

SAFER Act: Marijuana May Soon Become a Bigger Deal

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Proponents of marijuana reform have had cause for celebration in 2023. Despite challenges facing the industry, the political and social momentum surrounding cannabis is ticking upward. Most recently, the marijuana industry...more

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