News & Analysis as of

Pharmaceutical Industry Healthcare Reform Digital Health

McDermott Will & Emery

Trending in Telehealth: October 21 – 28, 2024

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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 & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

McDermott Will & Emery

Trending in Telehealth: June 11 – 17, 2024

McDermott Will & Emery on

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 & Emery

Trending in Telehealth: May 21 – May 27, 2024

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 & Emery

Trending in Telehealth: May 14 – May 20, 2024

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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 & Emery

Trending in Telehealth: April 23 – April 29, 2024

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 & Emery

Trending in Telehealth: February 12 – February 26, 2024

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

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

McDermott Will & Emery

Trending in Telehealth: January 29 – February 5, 2024

McDermott Will & Emery on

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 & Emery

Trending in Telehealth: January 4 – 15, 2024

McDermott Will & Emery on

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 & Emery

Trending in Telehealth: November 8 – 14, 2023

McDermott Will & Emery on

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

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q3 2023

Bass, Berry & Sims PLC on

After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more

McDermott Will & Emery

Trending in Telehealth: October 17 – 23, 2023

McDermott Will & Emery on

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 & Emery

Trending in Telehealth: October 11 – 16, 2023

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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

Wilson Sonsini Goodrich & Rosati

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

McDermott Will & Emery

Trending in Telehealth: September 19 – 25, 2023

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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

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

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

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Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

Manatt, Phelps & Phillips, LLP

[Webinar] Ten Health Care Imperatives for the 2020s: Navigating Through the Surges - May 24th, 12:00 pm - 1:00 pm ET

In January 2021, Manatt Health described the ten health care imperatives essential for improving our health care system and advancing health equity in the 2020s. Now two years into the decade, we have released our 2022...more

Morgan Lewis

How a Biden Administration Will Affect FDA’s Regulation of Medical Devices

Morgan Lewis on

Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more

Hogan Lovells

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software...

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On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more

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