Regulatory Oversight, Medical Devices, Drug Pricing

Five FDA Takeaways from the FY26 Budget

Akin Gump Strauss Hauer & Feld LLP on 6/3/2025

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

New ministerial guidance letter: a vague framework that contradicts three of the CEPS's positions while leaving it alone in charge...

Hogan Lovells on 5/12/2025

The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May...more

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

Akerman LLP - Health Law Rx on 8/26/2019

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

The South African pharmaceutical regulatory environment

Hogan Lovells on 6/20/2018

Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on 8/22/2017

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Regulatory Oversight › Medical Devices › Drug Pricing

Five FDA Takeaways from the FY26 Budget

New ministerial guidance letter: a vague framework that contradicts three of the CEPS's positions while leaving it alone in charge...

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

The South African pharmaceutical regulatory environment

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

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