News & Analysis as of

Regulatory Agenda Digital Health Regulatory Requirements

Gardner Law

Are FDA Review Timelines Slipping? What Companies Need to Know

Gardner Law on

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

McDermott Will & Schulte

Trending in Telehealth: January 6 – 27, 2025

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Schulte

Weight-Loss Programs in Florida: State Law Considerations for GLP-1 Telehealth Providers

As more telehealth providers offer weight-loss programs, they should be aware of the potential impact of state laws and regulations. In this blog post, we take a closer look at Florida’s consumer protection laws regarding...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

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