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Healthcare Rulemaking Process Life Sciences

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

Quarles & Brady LLP on

‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more

McDermott Will & Schulte

Trending in Telehealth: October 21 – 28, 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 & Schulte

Trending in Telehealth: September 30 – October 7, 2024

McDermott Will & Schulte 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 & Schulte

Trending in Telehealth: September 17 – 30, 2024

McDermott Will & Schulte 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 & Schulte

Trending in Telehealth: July 30 – August 12, 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 & Schulte

Trending in Telehealth: July 16 – 22, 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

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

Polsinelli on

As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

McDermott Will & Schulte

Trending in Telehealth: July 2 – 8, 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 & Schulte

Trending in Telehealth: May 14 – May 20, 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 & Schulte

Trending in Telehealth: May 7 – May 13, 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 & Schulte

Trending in Telehealth: April 30 – May 6, 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 & Schulte

Trending in Telehealth: February 5 – 12, 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 & Schulte

Trending in Telehealth: October 24 – 31, 2023

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

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

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