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News

State laws governing abortion raise questions over legality of embryonic stem cell research

New, or newly interpreted, state laws and court decisions governing abortion may directly affect access to medical care and treatment for patients who are, or who want to become, pregnant....

News

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

News

Podcast: Talking the cure

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...

Insights and Analysis

Senate proposes greater FDA oversight of Lab Developed Tests

On May 17, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee published a discussion draft of their FDA user fee program reauthorization package, the “Food and...

News

HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) ...

News

HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority

On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...

News

Expanded access to telehealth services during the COVID-19 pandemic

In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have...

News

The Coronavirus Aid, Relief, and Economic Security Act: Notable changes affecting Medicare and Medicaid

On March 27, 2020, Congress enacted into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), an unprecedented $2 trillion stimulus package intended to provide emergency...

News

COVID-19 threat prompts Florida’s Health Officials to expand telehealth under Emergency Order

On Monday, March 16, 2020, Florida’s Surgeon General issued a rare Emergency Order (the Order) that allows certain out-of-state health care professionals to temporarily provide...

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