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McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI Insights: Biden Administration Passes Sweeping Executive Order on Artificial Intelligence

On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...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

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Hogan Lovells

Actualités Législatives et Réglementaires – Janvier 2023

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Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de janvier 2023. Ces Actualités législatives et...more

Hogan Lovells

Actualités Législatives et Réglementaires – Novembre 2022

Hogan Lovells on

Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de novembre 2022. Ces Actualités législatives et...more

Manatt, Phelps & Phillips, LLP

The Manatt State Cost Containment Update - October 2021: Health Data Corner

The Health Data Corner compiles the latest state health care data capacity innovations and policy developments, as well as showcases novel data analytic use cases emerging from states. Other developments featured here include...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest

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Welcome to the first issue of the Latham & Watkins Drug Pricing Digest. Here, Latham’s government price reporting team provides a digest of recent developments, as reported in the trade press or published directly by...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: U.S. Senate to vote on relief package, an analysis of how data protection principles relate to vaccine passports...more

Latham & Watkins LLP

A Look Ahead at the Biden Administration’s Regulatory and Enforcement Priorities

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With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter- December 2020: Regulatory Updates

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Medicines and Medical Devices Bill (MMDB) – The MMDB is intended to act as the primary UK legislation specifying powers that would enable the regulatory regimes for human medicines, clinical trials, veterinary medicines and...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - December 2020: The UK National Security and Investment Bill

Dechert LLP on

The UK has announced a bill proposing a new system to screen transactions for national security risk, separate from the system of merger review operated by the Competition and Markets Authority. The National Security and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Hogan Lovells

U.S. Senate passes bill requiring prescription drug ads to include prices

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On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more

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