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Regulatory Reform Regulatory Oversight Pharmaceutical Industry

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Arnall Golden Gregory LLP

“Back in the U.S.A.”: FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing

Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing the FDA PreCheck...more

McDermott+

Trump Administration Executive Order Tracker - updated 8.18.25

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

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On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Husch Blackwell LLP

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know

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On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more

Hogan Lovells

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

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The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more

Mintz - Health Care Viewpoints

HHS Restructuring and Workforce Reductions – Key Implications for the Health Care Industry

As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

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The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Quarles & Brady LLP

Alabama Bill Proposes Rewrite of Pharmacy Practice Act

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The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

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Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Troutman Pepper Locke

Application for Last Available Medical Cannabis License in Virginia to Be Supervised by Virginia Cannabis Control Authority

Troutman Pepper Locke on

On October 2, the Virginia Board of Pharmacy posted a general notice indicating that it had voted to rescind the request for applications (RFA) for a Pharmaceutical Processor license in Health Service Area I. The RFA will now...more

Shook, Hardy & Bacon L.L.P.

Congress Gives FDA Oversight Over Cosmetics, Punts on Dietary Supplement Reforms

In a year-end $1.7 trillion spending package in late December, Congress voted to increase FDA's oversight of cosmetics and their ingredients. A portion of the bill titled the Modernization of Cosmetics Regulation Act requires...more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

Hogan Lovells

UK regulation of medical devices from 1 January 2021

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The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

Hogan Lovells

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

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The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

Akerman LLP - Health Law Rx

Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices

Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

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The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

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