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Healthcare Reform › Regulatory Oversight › Pharmaceutical Industry

Mintz - Health Care Viewpoints

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

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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

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

Holland & Knight LLP

Holland & Knight Health Dose: Pre-Election Outlook

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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....more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

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AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Hogan Lovells

Major regulatory changes in pharmaceutical laws and regulations in Spain for 2023

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The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including pricing and reimbursement or health...more

Hogan Lovells

First steps towards taking into account the organizational impacts of health care technologies

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On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance...more

Hogan Lovells

STeP’ing up: FDA advances expedited device review program, set to begin in March

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On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

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Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Hogan Lovells

FDA proposes new ways for prescription drugs to become available over-the-counter

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On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a...more

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